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Important Safety Information

Important Safety Information for ACUVUE® VITA® Brand Contact Lenses

ACUVUE® VITA® Brand Contact Lenses are indicated for vision correction as a daily wear lens with one-month recommended replacement. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available by visiting www.jnjvisionpro.com or by calling 1-800-843-2020.

Important Safety Information for all brands (except 1-DAY ACUVUE® DEFINE®)

ACUVUE® Brand Contact Lenses are indicated for vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information. Complete information is also available from Johnson & Johnson Vision Care, Inc., by calling 1-800-843-2020 or by visiting www.jnjvisionpro.com.

Important Safety Information for 1-DAY ACUVUE® DEFINE® Brand Contact Lenses

1-DAY ACUVUE® DEFINE® Brand Contact Lenses are available with and without vision correction. As with any contact lens, eye problems, including corneal ulcers, can develop. Some wearers may experience mild irritation, itching or discomfort. Lenses should not be prescribed if patients have any eye infection, or experience eye discomfort, excessive tearing, vision changes, redness or other eye problems. Consult the package insert for complete information, available from Johnson & Johnson Vision Care, Inc., by  calling 1-800-843-2020 or by visiting www.jnjvisionpro.com.

Important UV Information

Helps protect against transmission of harmful UV radiation to the cornea and into the eye.

WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses, because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long-term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.

For additional information about indications, contraindications, warnings and precautions for a particular product, please select the link below to download the product package insert.

1-DAY wear

1-DAY ACUVUE® DEFINE® with LACREON® Technology
1-DAY ACUVUE® TruEye® Brand (narafilcon A)
1-DAY ACUVUE® MOIST® Brand
1-DAY ACUVUE® MOIST® Brand for ASTIGMATISM
1-DAY ACUVUE® MOIST® Brand MULTIFOCAL
ACUVUE OASYS® 1-Day with HydraLuxe Technology
ACUVUE OASYS® 1-Day with HydraLuxe™ Technology for ASTIGMATISM

Two-week wear

ACUVUE® OASYS® with HYDRACLEAR®  PLUS Technology
ACUVUE® OASYS® for ASTIGMATISM
ACUVUE® OASYS® for PRESBYOPIA
ACUVUE® 2® Brand

Monthly Wear

ACUVUE® VITA® Brand Contact Lenses

ACUVUE® VITA® Brand for ASTGMATISM

 

ACUVUE RevitaLens Multi-Purpose Disinfecting Solution is indicated for the care of soft (hydrophilic) contact lenses, including silicone hydrogel lenses. Use this product, as recommended by your eye care professional, to disinfect, clean, rinse, store, remove protein and condition your lenses. If you are allergic to any ingredient in ACUVUE RevitaLens MPDS do not use this product. Problems with contact lenses and lens care products could result in corneal infection and/or ulcers and lead to loss of vision. It is essential that you follow your eye care professional’s directions and all labeling instructions for proper use of lenses and lens care products, including the lens case.  
 
Use Blink Contacts® Drops and Blink-N-Clean® Drops to lubricate and rewet soft and gas permeable contact lenses, to help relieve dryness and irritation that may be associated with lens wear and to cushion lenses by placing a drop on the eye prior to the application on the eye. If you are allergic to any ingredients in Blink Contacts® Drops or Blink-N-Clean® Drops, do not use this product.
 
Blink® Tears and Blink GelTears® Drops are for the temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun, and may be used as a protectant against further irritation. Patients should stop use if they experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.
 
Blink® Lid Wipes for effective removal of debris or other secretions on the eyelid and surrounding area. Do not re-use. Do not use wipe directly on the eye. Discontinue use if you are experiencing any redness, itching or irritation and consult your eye care professional. For external use only.
 
Blink® Omega-3 is FOR ORAL USE ONLY - DO NOT PUT IN THE EYE. Before taking this or any dietary supplement, consult your doctor especially if under medical supervision. Keep out of the reach of children. DO NOT FREEZE OR HEAT.

For additional information about indications, contraindications, warnings and precautions for a particular product, please select the link below to download the product package insert.

Blink Contacts® Drops

BLINK® Tears Lubricating Eye Drops

BLINK® Tears Perservative Free Drops

Blink GelTears® Drops

Blink-N-Clean® Drops

Blink® Lid Wipes

Blink RevitaLens® Multi-Purpose Disinfecting Solution

COMPLETE® MPS Easy Rub Formula

Oxysept® Disinfecting Solution/Neutralizer Ultracare® Formula

Ultrazyme® Enzymatic Cleaner

 

PP2018CN0005     CC17842

SUMMARY OF IMPORTANT SAFETY INFORMATION

Rx Only

FOR THE LIPIFLOW® THERMAL PULSATION SYSTEM

INDICATIONS FOR USE

The LipiFlow System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including Meibomian Gland Dysfunction (MGD), also known as Evaporative Dry Eye or Lipid Deficiency Dry Eye.

CONTRAINDICATIONS

Do not use the LipiFlow System in patients with the following conditions. Use of the device in patients with these conditions may cause injury. Safety and effectiveness of the device have not been studied in patients with these conditions.

  • Ocular surgery within prior 3 months, including intraocular, oculo-plastic, corneal or refractive surgery procedure
  • Ocular injury within prior 3 months
  • Ocular herpes of eye or eyelid within prior 3 months
  • Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids including a hordeolum or stye)
  • Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months (e.g., retinitis, macular inflammation, choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis)
  • Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
  • Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)

PRECAUTIONS

The Activator or Activator II (Disposable) may not fit all eyes, such as eyes with small palpebral fornices. Use of the LipiFlow System in patients with the following conditions may result in reduced treatment effectiveness because these conditions may cause ocular symptoms unrelated to cystic meibomian glands and require other medical management. Safety and effectiveness of the device have not been studied in patients with these conditions.

  • Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
  • Severe (Grade 3 or 4) eyelid inflammation (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis). Patients with severe eyelid inflammation should be treated medically prior to device use
  • Systemic disease conditions that cause dry eye (e.g., Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, Sjögren's syndrome)
  • Taking medications known to cause dryness (e.g., isotretinoin (Accutane®) and systemic antihistamines)
  • Esthetic eyelid and eyelash procedures (e.g., blepharoplasty, lash extensions, eyelid tattooing)

In addition, the treatment procedure may loosen previously inserted punctal plugs, which may worsen the patient’s dry eye symptoms.

POTENTIAL ADVERSE EFFECTS

Potential adverse effects that may occur as a result of the procedure include, but are not limited to, the onset or increase in

  • Eyelid/eye pain requiring discontinuation of the treatment procedure
  • Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, hordeolum or chalazion)
  • Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival edema or conjunctival injection (hyperemia)
  • Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, foreign body sensation, visual disturbance, sensitivity to light)

Potential serious adverse events (defined as permanent impairment or damage to a body structure or function or necessitates medical or surgical intervention to preclude permanent impairment or damage to a body structure or function) that are not anticipated because of the device mitigations to prevent occurrence include:

  • Thermal injury to the eyelid or eye, including conjunctiva, cornea or lens
  • Physical pressure-induced injury to the eyelid
  • Ocular surface (corneal) infection

 

FOR THE LIPISCANTM DYNAMIC MEIBOMIAN IMAGER

INDICATIONS FOR USE

LipiScan™ Dynamic Meibomian Imager (DMI) is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

CONTRAINDICATIONS

Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit.

PRECAUTIONS

Precautions provide information regarding any special care to be exercised by the practitioner for the safe and effective use of the device, as described below. Caution: Disinfect the surfaces of the chin rest, forehead rest and Handheld Near Infrared (IR) Lid Everter with isopropyl alcohol immediately prior to use and prior to storage to prevent cross-contamination and patient infection.

POTENTIAL ADVERSE EFFECTS

There are no known or anticipated adverse effects associated with use of this device.

 

FOR THE LIPIVIEW® II OCULAR SURFACE INTERFEROMETER

INDICATIONS FOR USE

The LipiView® II Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of:

  • Specular (interferometric) observations of the tear film. Using these images, LipiView II measures the absolute thickness of the tear film lipid layer.
  • Meibomian glands under near-infrared (NIR) illumination.
  • The ocular surface and eyelids under white illumination.

CONTRAINDICATIONS

Contraindications are conditions in which the device should not be used because the risk of use clearly outweighs any benefit. No contraindications have been identified for LipiView II.

PRECAUTIONS

The following patient conditions may affect the interferometry assessment of a patient’s tear film using LipiView II:

  • Use of ophthalmic drops such as artificial tear lubricants, ointments, and medications. Advise patients not not instill oil-based ophthalmic drops (e.g., Soothe®, Restasis®, Systane Balance®) for at least 12 hours prior to device use and not to instill ointments for at least 24 hours prior to device use. Wait at least four (4) hours after the instillation of all other ophthalmic drops prior to device use.
  • Soft or rigid contact lens wear. Advise patients to remove contact lenses at least four hours prior to device use.
  • Use of oil-based facial cosmetics around the eye.
  • Eye rubbing.
  • Recent swimming in a chlorinated pool. Advise pateints to not to swim for at least 12 hours prior to device use.
  • Any ocular surface condition that affects the stability of the tear film. These conditions include disease, dystrophy, trauma, scarring, surgery, or abnormality.

POTENTIAL ADVERSE EFFECTS

There are no known or anticipated adverse effects associated with use of this device.

 

FOR THE MEIBOMIAN GLAND EVALUATOR

INDICATIONS FOR USE

The Meibomian Gland Evaluator is a hand held instrument used by a physician to evaluate Meibomian gland secretions in adult patients during a routine eye examination. The instrument provides a standardized method to apply consistent, gentle pressure to the outer skin of the lower eyelid while visualizing the secretions from the Meibomian gland orifices through a slit lamp biomicroscope.

CONTRAINDICATIONS

No contraindications are known.

PRECAUTIONS

  • Do not depress the shaft to the endpoint of the spring. Do not apply any additional force after the shaft has been depressed approximately 6 mm. Applying additional force negates the benefit of using the instrument to apply standard force.
  • Familiarity with use of a slit lamp biomicroscope is required to use Meibomian Gland Evaluator for assessment of the meibomian gland secretions.

WARNINGS

To ensure proper use of the Meibomian Gland Evaluator, review the warnings below.

  • Do not use Meibomian Gland Evaluator if the package is open or broken. Do not use Meibomian Gland Evaluator if it appears broken or has sharp edges or rough surfaces upon initial inspection.
  • Maintain proper infection control procedures including cleaning hands before handling the device and before evaluation of each patient. Disinfect the instrument with alcohol after each use and between patients.
  • Avoid contact of the devices with the eye. Instruct the patient to look up and away to avoid injury to the cornea in the event the contact surface inadvertently touches the eye.

 

POTENTIAL ADVERSE EFFECTS

Potential adverse effects that are unlikely but may occur with use of the Meibomian Gland Evaluator include but are not limited to:

  • Skin abrasion (e.g., from a rough surface on the device)
  • Eye abrasion (e.g., from improper contact of the instrument with the eye)
  • Infection of the skin or eye (e.g., from improper or lack of disinfection after use and between patients)
  • Allergic or toxic reaction (e.g., from exposure to any residue on device during user handling)

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® MULTIFOCAL 1-PIECE IOLS, MODELS ZKB00 AND ZLB00

Rx Only

INDICATIONS

The TECNIS® Multifocal 1-Piece Intraocular lenses, Models ZKB00 (+2.75 D) and ZLB00 (+3.25 D), are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.

PRECAUTIONS

Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave.

ADVERSE EVENTS

Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically higher than the FDA grid rate (for both first and second eyes).

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR
BAERVELDT® GLAUCOMA IMPLANT

Rx Only

INDICATIONS

For use in patients (with prior vitrectomy for Pars Plana) with medically uncontrollable glaucoma and poor surgical prognosis, such as, but not limited to: neovascular glaucoma, aphakic/pseudophakic glaucomas, patients who have failed conventional surgery, congenital glaucomas and secondary glaucomas due to uveitis, epithelial downgrowth, etc.

CONTRAINDICATIONS

Bacterial conjunctivitis, bacterial corneal ulcers, endophthalmitis, orbital cellulites, bacteremia or septicemia, active scleritis and/or no light perception.

WARNINGS

Do not use the device if sterile package integrity has been compromised. Do not resterilize the implant by any method. Do not reuse the implant. Do not store at temperatures above 113°F (45°C). Johnson & Johnson Surgical Vision, Inc. (JJSV) single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

COMPLICATIONS/ADVERSE EVENTS

The complications during and after surgery include, but are not limited to: choroidal hemorrhage, hyphema, serous choroidal effusion, hypotony, flat anterior chamber, phthisis bulbi, retinal detachment, endophthalmitis, tube erosion, tube touch to cornea, tube block by iris or vitreous, bullous keratopathy, uveitis and diplopia.

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
TECNIS
® TORIC II 1-PIECE IOL

Rx Only

INDICATIONS

The TECNIS® Toric II 1-Piece posterior chamber lenses are indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric II 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or uveitis; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The clinical study for the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS® Toric II 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric II 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Do not soak or rinse with any solution other than sterile balanced salt solution or sterile normal saline. Do not store in direct sunlight or at greater than 113oF. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS® Toric II 1-Piece IOL with the intended axis of placement. When the insertion system is used improperly, the haptics of the TECNIS® Toric II 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. The use of methods other than the TECNIS® Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TECNIS®ToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions, and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Pre-existing conditions include: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, or irregular corneal astigmatism. Intraoperative conditions include: excessive vitreous loss, capsulotomy by any technique other than a circular tear, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.), capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS® Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS® Toric II intraocular lens labeling. Please refer to the TECNIS® Toric Calculator user manual for more information.

All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS® Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, pupillary block, retinal detachment, IOL dislocation, persistent corneal stromal edema, persistent cystoid macular edema, or secondary surgical intervention (including implant repositioning, removal, or other surgical procedure). The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

INDICATIONS and IMPORTANT SAFETY INFORMATION for
TECNIS EyhanceTM and
TECNIS EyhanceTM Toric II IOLs with TECNIS Simplicity® Delivery System

Rx Only

INDICATIONS FOR USE

The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS EyhanceTM IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS EyhanceTM Toric II IOLs for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with any of the following conditions may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the patient’s eyesight. These conditions are not specific to the design of the lens and are attributed to cataract surgery and IOL implantation in general: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye, b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, c. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), d. A compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible, e. Circumstances that would result in damage to the endothelium during implantation, f. Suspected microbial infection, g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL, h. Congenital bilateral cataracts, i. Previous history of, or a predisposition to, retinal detachment, j. Patients with only one good eye with potentially good vision, k. Medically uncontrollable glaucoma, l. Corneal endothelial dystrophy, m. Proliferative diabetic retinopathy, n. Children under the age of 2 years are not suitable candidates for intraocular lenses, The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus, Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The clinical study for the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. Rotation of the toric lens from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the delivery system is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.

PRECAUTIONS

The safety and effectiveness of the TECNIS EyhanceTM IOL and
TECNIS EyhanceTM Toric II IOL has not been substantiated in clinical trials. The effects of the TECNIS EyhanceTM IOL optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. MTF testing of the TECNIS EyhanceTM IOL may aid the Surgeon in understanding the theoretical image quality expected with the
TECNIS EyhanceTM IOL compared to other JJSV monofocal IOLs (AAB00 and ZCB00). However, these do not fully assess all aspects of clinical difficulties under all conditions. Surgeons must weigh the potential benefits of the modified optical design of the TECNIS EyhanceTM IOL against the potential for risks and the lack of clinical data to characterize the impact of the TECNIS EyhanceTM IOL optical design on contrast sensitivity and subjective visual disturbance. These considerations may be especially relevant to patients with certain pre-existing ocular conditions (prior corneal refractive surgery, irregular corneal astigmatism, severe corneal dystrophy, macular disease, optic nerve atrophy, etc.) or intraoperative conditions (posterior capsular rupture, complications in which the IOL stability could be compromised, inability to place IOL in capsular bag, etc.). Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Some autorefractors utilize only the central part of the IOL to calculate the refraction of the eye and that is the region where the TECNIS EyhanceTM deviates from the monofocal design which could result in a wrong estimation of the refraction. Manual refraction with maximum plus technique is strongly recommended. Recent contact lens usage may affect the patient's refraction; therefore, for patients who wear contact lenses, surgeons should establish corneal stability without contact lenses prior to determining IOL power. The lens is designed for optimum visual performance when emmetropia is targeted. This is a single use device, do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the delivery system. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balanced salt solution (BSS) or viscoelastics is required when using the delivery system. For optimal performance when using OVD, use the HEALON® family of viscoelastics. The use of BSS with additives has not been studied for this product. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised. Do not leave the lens in a folded position more than 10 minutes. When the delivery system is used improperly, the lens may not be delivered properly (i.e., haptics may be broken). Please refer to the specific instructions for use provided. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS EyhanceTM Toric II IOL with the intended axis of placement. The use of methods other than the TECNIS® Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study for the TECNIS® Toric 1-Piece IOLs. and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the
TECNIS EyhanceTM Toric II IOLs have not been substantiated in patients with the following preexisting ocular conditions and intraoperative complications (see below). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Before Surgery: Choroidal hemorrhage, Chronic severe uveitis, Concomitant severe eye disease, Extremely shallow anterior chamber, Medically uncontrolled glaucoma, Microphthalmos, Non-age-related cataract, Proliferative diabetic retinopathy (severe), Severe corneal dystrophy, Severe optic nerve atrophy, Irregular corneal astigmatism. During Surgery: Excessive vitreous loss, Capsulotomy by any technique other than a circular tear, The presence of radial tears known or suspected at the time of surgery, Situations in which the integrity of the circular tear cannot be confirmed by direct visualization, Cataract extraction by techniques other than phacoemulsification or liquefaction, Situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.), Capsular rupture, Significant anterior chamber hyphema, Uncontrollable positive intraocular pressure, Zonular damage. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS® Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS® Toric intraocular lens labeling. Please refer to the Johnson & Johnson Surgical Vision, Inc. Toric Calculator user manual for more information. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes, and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study for the TECNIS® Toric 1-Piece IOLs. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS® Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent iritis, persistent raised IOP (intraocular pressure) requiring treatment, acute corneal decompensation, secondary surgical intervention (including implant repositioning, removal, or other surgical procedure) and any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. The most frequently reported cumulative adverse event that occurred during the SENSAR® 1-Piece IOL clinical trial was cystoid macular edema which occurred at a rate of 3.3%. Other reported events included secondary surgical intervention (pars plana vitrectomy with membrane peel) which occurred at a rate of 0.8% and lens exchange (torn haptic related to improper loading technique) which occurred at a rate of 0.8%. The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGYTM IOL WITH TECNIS SIMPLICITY® DELIVERY SYSTEM, MODEL DFR00V AND TECNIS SYNERGYTM TORIC II IOL WITH TECNIS SIMPLICITY® DELIVERY SYSTEM, MODELS DFW150, DFW225, DFW300, DFW375

RX Only

INDICATIONS FOR USE

The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS SynergyTM IOL, which is indicated for primary implantation for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the TECNIS SynergyTM Toric II IOLs that are indicated for primary implantation for the visual correction of aphakia and for reduction of refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. Compared to an aspheric monofocal lens, the TECNIS SynergyTM IOLs mitigate the effects of presbyopia by providing improved visual acuity at intermediate and near distances to reduce eyeglass wear, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

PRECAUTIONS

1. This is a single use device. Do not resterilize the lens or the delivery system. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects.
2. Do not store the device in direct sunlight or at a temperature under 41°F (5°C) or over 95°F (35°C).
3. Do not autoclave the delivery system.
4. Do not advance the lens unless ready for lens implantation.
5. The contents are sterile unless the package is opened or damaged.
6. The recommended temperature for implanting the lens is at least 63°F (17°C).
7. The use of balanced salt solution (BSS) or viscoelastics is required when using the delivery system. For optimal performance when using OVD, use the HEALON® family of viscoelastics. The use of BSS with additives has not been studied for this product.
8. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the delivery system and/or the lens may have been compromised.
9. When performing refraction in patients implanted with the lens, interpret results with caution when using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is strongly recommended.
10. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design.
11. Recent contact lens usage may affect the patient’s refraction; therefore, in contact lens wearers, surgeons should establish corneal stability without contact lenses prior to determining IOL power.
12. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.
13. Care should be taken to achieve centration of the intraocular lens in the capsular bag.
14. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of the device and provide them a copy of the patient information brochure.
15. Children under the age of 2 years are not suitable candidates for intraocular lenses.
16. The lens should not be placed in the ciliary sulcus.
17. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the toric lens with the intended axis of placement.
18. The TECNIS® Toric IOL Calculator includes a feature that accounts for posterior corneal astigmatism (PCA). The PCA is based on an algorithm that combines published literature (Koch, et al., 2012) and a retrospective analysis of data from a TECNIS® Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in the prospective TECNIS® Toric IOL U.S. IDE study and may yield results different from those in the TECNIS SynergyTM Toric II IOL labeling. Please refer to the TECNIS® Toric IOL Calculator user manual for more information.
19. The use of methods other than the TECNIS® Toric IOL Calculator to select cylinder power and appropriate axis of implantation were not assessed in the TECNIS® Toric IOL U.S. IDE study and may not yield similar results. Accurate keratometry and biometry, in addition to the use of the TECNIS® Toric IOL Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes for the toric lens.
20. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, the surgeon's estimated surgically induced astigmatism (SIA) and biometry. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The effectiveness of TECNIS SynergyTM Toric II IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism <1.0 diopter has not been demonstrated.
21. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS SynergyTM and TECNIS SynergyTM Toric IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism.
22. All corneal incisions were placed temporally in the TECNIS® Toric IOL U.S. IDE study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained for the TECNIS® Toric IOL. Note that the TECNIS® Toric IOL Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.
23. Do not reuse.
24. The safety and effectiveness of the TECNIS SynergyTM IOL have not been substantiated in patients under the age of 22 or those with preexisting ocular conditions and intraoperative complications, including those specified in the Warnings and Precautions, such as pupil abnormalities, prior corneal refractive or intraocular surgery, acute or chronic ophthalmic diseases or conditions (see below for examples). Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions.

Before Surgery

  • Pupil abnormalities
  • Prior corneal refractive or intraocular surgery
  • Choroidal hemorrhage
  • Chronic severe uveitis
  • Concomitant severe eye disease
  • Extremely shallow anterior chamber
  • Medically uncontrolled glaucoma
  • Microphthalmos
  • Non-age-related cataract
  • Proliferative diabetic retinopathy (severe)
  • Severe corneal dystrophy
  • Severe optic nerve atrophy
  • Irregular corneal astigmatism
  • Amblyopia
  • Macular disease
  • Pregnancy

During Surgery

  • Excessive vitreous loss
  • Non-circular capsulotomy/capsulorhexis
  • The presence of radial tears known or suspected at the time of surgery
  • Situations in which the integrity of the circular capsulotomy/capsulorhexis cannot be confirmed by direct
  • visualization
  • Cataract extraction by techniques other than phacoemulsification or liquefaction
  • Capsular rupture
  • Significant anterior chamber hyphema
  • Uncontrollable positive intraocular pressure
  • Zonular damage

Potential complications generally associated with cataract surgery include, but are not limited to: endophthalmitis/intraocular infection, hypopyon, hyphema, IOL dislocation, persistent cystoid macular edema, pupillary block, retinal detachment/tear, persistent corneal stromal edema, persistent uveitis, persistent raised intraocular pressure (IOP) requiring treatment (e.g., AC tap), retained lens material, or toxic anterior segment syndrome, or any other adverse event that leads to permanent visual impairment or requires surgical or medical intervention to prevent permanent visual impairment. Adverse events that may be associated with use of the device include: IOL dislocation, tilt or decentration, visual symptoms requiring lens removal, residual refractive error, secondary surgical intervention (including IOL repositioning or removal).

25. Do not leave the lens in a folded position more than 10 minutes.
26. When the delivery system is used improperly, the lens may not be delivered properly, (i.e., haptics may be broken). Please refer to the specific instructions for use provided.

WARNINGS

1. Intraocular lenses may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition or may pose an unreasonable risk to the eyesight of patients with: a. Recurrent severe anterior or posterior segment inflammation of unknown etiology, b. Posterior segment diseases of which monitoring or treatment ability may be limited by an intraocular lens, c. Surgical difficulties at the time of cataract extraction and/or intraocular lens implantation that might increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure, or significant vitreous prolapse or loss), d. Compromised posterior capsule or zonules due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, e. Risk of damage to the endothelium during implantation, f. Suspected microbial infection, g. Congenital bilateral cataracts, h. Previous history of, or a predisposition to, retinal detachment, i. Potentially good vision in only one eye, j. Medically uncontrollable glaucoma, k. Corneal endothelial dystrophy, l. Proliferative diabetic retinopathy.
2. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starbursts or glare around lights), which may be expected in nighttime or poor visibility conditions. Patients may perceive these visual effects as bothersome, which, on rare occasions, may be significant enough for the patient to request removal of the IOL.
3. A reduction in contrast sensitivity compared to an aspheric monofocal IOL may be experienced by some patients under certain conditions. The physician should carefully weigh the potential risks and benefits for each patient, with special consideration of potential visual problems before implanting the lens in patients including those with macular disease, amblyopia, corneal irregularities, or other ocular disease that may cause present or future reduction in acuity or contrast sensitivity, and should fully inform the patient of the potential for reduced contrast sensitivity and to exercise caution when driving at night or in poor visibility conditions after implantation.
4. Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully benefit in terms of reducing spectacle wear.
5. Rotation of the toric lens from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.
6. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can significantly affect the function and/or structural integrity of the design.
7. Do not use if the cartridge of the delivery system is cracked or split prior to implantation.
8. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system.
9. During initial lens advancement (Figure 11), quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens.
10. After initial lens advancement (Figure 11) and the half turn rotation step (Figure 12), do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge.
11. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge.
12. Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the delivery system minimizes the risk of infection and/or inflammation associated with contamination.
13. The reuse/resterilization/reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® MONOFOCAL 1-PIECE IOL WITH TECNIS iTEC® PRELOADED DELIVERY SYSTEM

Rx Only

INDICATIONS

The TECNIS® 1-Piece Lens is indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: Patients with recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL; children under the age of 2 years are not suitable candidates for intraocular lenses. Do not attempt to disassemble, modify or alter this device or any of its components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated for use with the
TECNIS iTec® Preloaded Delivery System. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the cartridge. Do not push the plunger forward to fully advance the lens until ready for lens implantation. Discard the device if the lens has been fully advanced for more than 1 minute. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the
TECNIS iTec® Preloaded Delivery System minimizes the risk of infection and/or inflammation associated with contamination. The reuse/resterilization/reprocessing of JJSV single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The TECNIS® 1-piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

PRECAUTIONS

Do not resterilize the lens or the
TECNIS iTec® Preloaded Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the device. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C. The combination of low operating room temperatures and high IOL diopter powers may require slower delivery. The use of viscoelastics is required when using the
TECNIS iTec® Preloaded Delivery System. For optimal performance, use the JJSV HEALON® family of viscoelastics. The use of balanced salt solution alone is not recommended. Do not use if the TECNIS iTec® Preloaded Delivery System has been dropped or if any part was inadvertently struck while outside the shipping case.

ADVERSE EVENTS

The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic).

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS® 1-PIECE IOL WITH THE TECNIS SIMPLICITY® DELIVERY SYSTEM

Rx Only

ATTENTION

Reference the Directions for Use labeling for a complete listing of indications and important safety information.

INDICATIONS

The TECNIS Simplicity® Delivery System is used to fold and assist in inserting the
TECNIS® 1-Piece intraocular lens for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

This is a single use device, do not re-sterilize the lens or the
TECNIS Simplicity® Delivery System. Most sterilizers are not equipped to sterilize the soft acrylic material and the preloaded inserter material without producing undesirable side effects. Do not store the device in direct sunlight or at a temperature under 5°C (41°F) or over 35°C (95°F). Do not autoclave the
TECNIS Simplicity® Delivery System. Do not advance the lens unless ready for lens implantation. The contents are sterile unless the package is opened or damaged. The recommended temperature for implanting the lens is at least 17°C (63°F). The use of balanced salt solution (BSS) or viscoelastics is required when using the TECNIS Simplicity® Delivery System. For optimal performance when using OVD, use the HEALON® family of viscoelastics. The use of BSS with additives has not been studied for this product. Do not use if the
TECNIS Simplicity® Delivery System has been dropped or if any part was inadvertently struck while outside the shipping box. The sterility of the TECNIS Simplicity® Delivery System and/or the lens may have been compromised. When the insertion system is used improperly, the haptics of the TECNIS® 1-piece lens may become damaged.  

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: a. Patients with recurrent severe anterior or posterior segment inflammation or uveitis. b. Patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases. c. Surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss). d. A compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible. e. Circumstances that would result in damage to the endothelium during implantation. f. Suspected microbial infection. g. Patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. h. Children under the age of 2 years are not suitable candidates for intraocular lenses. Do not attempt to disassemble, modify or alter the TECNIS Simplicity® Delivery System or any of its components, as this can significantly affect the function and/or structural integrity of the design. Do not use if the cartridge of the TECNIS Simplicity® Delivery System is cracked or split prior to implantation. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the TECNIS Simplicity® Delivery System. During initial lens advancement, quick advancement of the plunger is needed. Do not stop or reverse while advancing the plunger. Doing so may result in improper folding of the lens. After initial lens advancement and the half turn rotation step, do not move the plunger forward until ready for lens implantation. Doing so may result in the lens being stuck in the cartridge. The lens and TECNIS Simplicity® Delivery System should be discarded if the lens has been folded within the cartridge for more than 10 minutes. Not doing so may result in the lens being stuck in the cartridge. Johnson & Johnson Surgical Vision, Inc. single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. When used according to the directions for use, the TECNIS Simplicity® Delivery System minimizes the risk of infection and/ or inflammation associated with contamination. The reuse / re-sterilization / reprocessing of Johnson & Johnson Surgical Vision, Inc. single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility. The TECNIS® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the
TECNIS Simplicity® Delivery System.

Adverse Events

The most frequently reported adverse event that occurred during the clinical trial of the 1-Piece IOL was cystoid macular edema, which occurred at a rate of 3.3%. Other reported events occurring in less than 1% of patients were secondary surgical intervention (0.8%, vitrectomy) and lens exchange (0.8%, due to torn lens haptic). 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE TECNIS SYMFONYTM AND
TECNIS SYMFONYTM TORIC EXTENDED RANGE OF VISION IOLs

Rx Only

INDICATIONS

The TECNIS SymfonyTM IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The TECNIS SymfonyTM IOL, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. These models of IOLs, ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, these models of IOLs provide improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. These models of IOLs are intended for capsular bag placement only.

WARNINGS

Patients with any of the conditions described in the Directions for Use may not be suitable candidates for an intraocular lens because the lens may exacerbate an existing condition, may interfere with diagnosis or treatment of a condition, or may pose an unreasonable risk to the patient’s eyesight. Lenses should not be placed in the ciliary sulcus. May cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL; fully inform the patient of this risk before implanting the lens. Special consideration should be made in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease. Inform patients to exercise special caution when driving at night or in poor visibility conditions. Some visual effects may be expected due to the lens design, including: a perception of halos, glare, or starbursts around lights under nighttime conditions. These will be bothersome or very bothersome in some people, particularly in low-illumination conditions, and on rare occasions, may be significant enough that the patient may request removal of the IOL. Rotation of the The
TECNIS SymfonyTM Toric IOL away from their intended axis can reduce their astigmatic correction, and misalignment ˃30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS

Interpret results with caution when refracting using autorefractors or wavefront aberrometers that utilize infrared light, or when performing a duochrome test. Confirmation of refraction with maximum plus manifest refraction technique is recommended. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the optical design. Target emmetropia for optimum visual performance. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions. For the TECNIS SymfonyTM Toric IOL, variability in any preoperative surgical parameters (e.g. keratometric cylinder, incision location, surgeon’s estimated surgically induced astigmatism and biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case to prevent lens rotation.

SERIOUS ADVERSE EFFECTS

The most frequently reported serious adverse events that occurred during the clinical trial of the TECNIS SymfonyTM lens were cystoid macular edema (2 eyes, 0.7%) and surgical reintervention (treatment injections for cystoid macular edema and endophthalmitis, 2 eyes, 0.7%). No lens-related adverse events occurred during the trial.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
SENSAR® MONOFOCAL 1-PIECE IOL

Rx Only

INDICATIONS

SENSAR® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not reuse lens. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the SENSAR® 1-Piece Lens may become damaged.

WARNINGS

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio: patients with recurrent severe anterior or posterior segment inflammation or uveitis, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), a compromised eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, and patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. Johnson & Johnson Surgical Vision IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/ or illness due to product contamination, transmission of infection, and lack of product sterility. The SENSAR® 1-Piece IOL should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus.

ADVERSE EVENTS

The most frequently reported cumulative adverse event that occurred during the clinical trial of the lens was cystoid macular edema, which occurred at a rate of 3.3%. Other reported adverse events include lens exchange and secondary surgical intervention, which occurred at a rate of 0.8%.

ATTENTION

Reference the labeling for a complete listing of Important Indications and Safety Information.

FOR THE UNFOLDER® PLATINUM 1 SERIES IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The Model DK7796 Handpiece is used in combination with the Model 1MTEC30 Cartridge to fold and assist in inserting Johnson & Johnson Surgical Acrylic 1-Piece Intraocular Lenses, ONLY into the capsular bag.

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The UNFOLDER® Platinum 1 Series Implantation System should be used ONLY with JJSV Acrylic 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methyl cellulose viscoelastics is not recommended as they have not been validated with the Model 1MTEC30 Cartridge and JJSV acrylic 1-Piece IOLs. Do not implant lens if rod tip becomes jammed in the cartridge. JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the JJSV HEALON® Family of Viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of the UNFOLDER® Platinum 1 Series Implantation System has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F.

FOR THE UNFOLDER® EMERALD IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The UNFOLDER® Emerald Series Implantation System is used to fold and assist in inserting JJSV acrylic intraocular lenses, ONLY into the capsular bag.

WARNINGS

The UNFOLDER® Emerald Series Implantation System should only be used with JJSV acrylic OptiEdge IOLs. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. The lens and cartridge should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. Never reverse the rod direction until the optic body has been completely released. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. If the IOL is not properly placed in the cartridge, the lens may flip and be implanted upside down. The UNFOLDER® Emerald Series Cartridge is intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. Do not advance an intraocular lens through a given cartridge more than once. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design.

WARNINGS (CARTRIDGE ONLY)

JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Overall system performance will be impaired when used in combination with non-JJSV products. The use of viscoelastics is required when loading the IOL into the UNFOLDER® Emerald Cartridge. Do not use balanced salt solution. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F or over 86°F. Inconsistent results have been found when using some methylcellulose viscoelastics. Avoid using these viscoelastics if high forces are observed while advancing the intraocular lens through the cartridge.

FOR THE UNFOLDER® SILVER SERIES IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The UNFOLDER® Silver Series Implantation System is used to fold and assist in inserting CLARIFLEX, PHACOFLEX II, CeeOn, TECNIS® Silicone, and ARRAY Silicone ≤ 24.0 D IOLs only, into the eye. 

WARNINGS

The UNFOLDER® Silver Series Implantation System should only be used with the intraocular lenses listed in the Indication for Use section. Do not use this device or any of its components with any other lens. If the cartridge tip is cracked or split prior to implantation, do not use. The lens, cartridge, and sheath should be discarded if the lens is in the advanced position for more than 30 seconds or if the lens has been folded in any position within the cartridge for more than 5 minutes. Never reverse the rod direction until the optic body has been completely released. If an IOL haptic is caught between the wings of the cartridge, the haptic may become detached from the IOL body during implantation. If the IOL is not properly placed in the cartridge, the IOL may flip and be implanted upside down. The
UNFOLDER® Silver Series Implantation Cartridge, Silver Series SofTip Sheath, and Silver Series SofTip Applicator are intended for single use only. Discard after a single use. Do not autoclave or resterilize by any method. Do not advance an IOL through a given cartridge more than once. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Never use the UNFOLDER® Implantation System without a SofTip Sheath applied to the end of the handpiece rod. Always ensure that the SofTip Sheath is fully engaged on the handpiece rod tip. If it is not, use your sterile-gloved finger to engage the tip firmly against the shoulder of the rod. Avoid methylcellulose viscoelastics. Follow the dwell recommendations for advanced position of the IOL.

WARNING (Cartridge Only):

JJSV single-use medical devices are labeled with instructions for use and handling to minimize exposure to conditions which may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Do not use the cartridge if the package has been damaged. Overall system performance will be impaired when used in combination with non JJSV product. The usage of a viscoelastic is required when loading the IOL into the UNFOLDER® Cartridge. Do not use balanced salt solution. Do not use if the instrument has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F (5°C) or over 86°F (30°C). For optimal performance use the AMO
HEALON® Ophthalmic Viscoelastic Solution.

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
TECNIS® MULTIFOCAL 1-PIECE IOLs

Rx Only

INDICATIONS

The TECNIS® Multifocal 1-Piece intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions.

PRECAUTIONS

Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. The long term effects of intraocular lens implantation have not been determined. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received lens implants. Do not reuse, resterilize or autoclave.

ADVERSE EVENTS

The rates of surgical re-interventions, most of which were non-lens related, were statistically higher than the FDA grid rate for both the ZMB00 (+4.00 D) and ZLB00 (+3.25 D) lens models. For the ZMB00, the surgical re-intervention rates were 3.2% for first eyes and 3.3% for second eyes. The re-intervention rate was 3.3% for both the first and second eyes in the ZLB00 group.

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the
TECNIS® Multifocal Toric II IOLs

Rx Only

 

INDICATIONS 

The TECNIS® Multifocal Toric II lens models ZKU150, ZKU225, ZKU300, ZKU375 and ZLU150, ZLU225, ZLU300, ZLU375 are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with or without presbyopia, with greater than or equal to 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has been removed in order to provide near, intermediate and distance vision. The IOLs are intended for capsular bag placement only.

 

WARNINGS

Physicians considering lens implantation should weight the potential risk/benefit ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes.  Multifocal IOL implants may be inadvisable in patients where central visual field reduction may not be tolerated, such as macular degeneration, retinal pigment epithelium changes, and glaucoma. The lens should not be placed in the ciliary sulcus. Inform patients about the possibility that a decrease in contrast sensitivity and an increase in visual disturbances may affect their ability to drive a car under certain environmental conditions, such as driving at night or in poor visibility conditions. The clinical study of the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. Rotation of the TECNIS® Multifocal Toric II IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder.

 

PRECAUTIONS

Prior to surgery, inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to patient. Secondary glaucoma has been reported occasionally in patients with controlled glaucoma who received TECNIS® Multifocal IOL implants. The long term effects of intraocular lens implantation have not been determined.

Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes with TECNIS® Multifocal Toric II IOLs. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the TECNIS® Toric 1-Piece IOL clinical study. Do not reuse, resterilize, or autoclave.

 

ADVERSE EVENTS

Only the rate (3.3%) of surgical re-interventions, most of which were non-lens-related, in the ZLB00 (+3.25 D) lens group, was statistically higher than the FDA grid rate (for both first and second eyes). The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). 

 

ATTENTION

Reference the Directions for Use for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR
TECNIS® MONOFOCAL 1-PIECE IOL

Rx Only

INDICATIONS

TECNIS® 1-Piece Lenses are indicated for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. These devices are intended to be placed in the capsular bag.

PRECAUTIONS

Do not resterilize the lens. Most sterilizers are not equipped to sterilize the soft acrylic material without producing undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 113°F (45°C). Do not autoclave the intraocular lens. Please refer to the specific instructions for use provided with the insertion instrument or system for the amount of time the IOL can remain folded before the IOL must be discarded. When the insertion system is used improperly, the haptics of the TECNIS® 1-Piece Lens may become damaged.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any conditions described in the TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These conditions include recurrent severe anterior or posterior segment inflammation or uveitis; patients in whom the intraocular lens may affect the ability to observe, diagnose, or treat posterior segment diseases; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus.

ADVERSE EVENTS

In 3.3% of patients, reported adverse events of cataract surgery with the 1-Piece IOL included macular edema. Other reported reactions occurring in less than 1% of patients were secondary surgical intervention (pars plana vitrectomy with membrane peel) and lens exchange (due to torn lens haptic).

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
TECNIS® TORIC 1-PIECE IOL

Rx Only

INDICATIONS

The TECNIS® Toric 1-Piece Posterior Chamber Lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. These circumstances include recurrent severe anterior or posterior segment inflammation or uveitis; surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss); a compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible; circumstances that would result in damage to the endothelium during implantation; suspected microbial infection; or patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL. Children under the age of 2 years are not suitable candidates for intraocular lenses. The clinical study for the
TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of < 1.0 diopter. The TECNIS® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation.

PRECAUTIONS

Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Do not soak or rinse with any solution other than sterile balanced salt solution or sterile normal saline. Do not store in direct sunlight or at greater than  113°F. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or over-inflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS® Toric 1-Piece IOL with the intended axis of placement. When the insertion system is used improperly, the haptics of the TECNIS® Toric 1-Piece IOL may become broken. Please refer to the specific instructions for use provided with the insertion instrument or system. The use of methods other than the TECNIS® Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the clinical study and may not yield similar results. Accurate keratometry and biometry in addition to the use of the TECNIS® Toric Calculator (www.TecnisToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions, and intraoperative complications. Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient with one or more of these conditions. Preexisting conditions include: choroidal hemorrhage, chronic severe uveitis, concomitant severe eye disease, extremely shallow anterior chamber, medically uncontrolled glaucoma, microphthalmos, non-age-related cataract, proliferative diabetic retinopathy (severe), severe corneal dystrophy, severe optic nerve atrophy, or irregular corneal astigmatism. Intraoperative conditions include: excessive vitreous loss, capsulotomy by any technique other than a circular tear, the presence of radial tears known or suspected at the time of surgery, situations in which the integrity of the circular tear cannot be confirmed by direct visualization, cataract extraction by techniques other than phacoemulsification or liquefaction, situations where the need for a large capsulotomy can be anticipated (e.g., diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.), capsular rupture, significant anterior chamber hyphema, uncontrollable positive intraocular pressure, zonular damage. All preoperative surgical parameters are important when choosing a toric lens for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeon’s estimated surgically induced astigmatism (SIA) and biometry. The PCA is based on an algorithm that combines published literature (Koch et.al, 2012) and a retrospective analysis of data from a TECNIS® Toric multi-center clinical study. The PCA algorithm for the selection of appropriate cylinder power and axis of implantation was not assessed in a prospective clinical study and may yield results different from those in the TECNIS® Toric intraocular lens labeling. Please refer to the Johnson & Johnson Surgical Vision Toric Calculator user manual for more information. Variability in any of the preoperative measurements can influence patient outcomes and the effectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. All corneal incisions were placed temporally in the clinical study. If the surgeon chooses to place the incision at a different location, outcomes may be different from those obtained in the clinical study. Note that the TECNIS® Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options. Do not reuse, resterilize, or autoclave.

ADVERSE EVENTS

Potential adverse events during or following cataract surgery with implantation of an IOL may include but are not limited to: endophthalmitis/intraocular infection, hypopyon, pupillary block, retinal detachment, IOL dislocation, persistent corneal stromal edema, persistent cystoid macular edema, or secondary surgical intervention (including implant repositioning, removal, or other surgical procedure). The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included cystoid macular edema which occurred at a rate of 2.9% and retinal detachment which occurred at a rate of 0.6%.

IMPORTANT SAFETY INFORMATION FOR
TECNIS® CL 3-PIECE IOLs

Rx Only

INDICATIONS

TECNIS® CL Silicone intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction or phacoemulsification. These devices are intended to be placed in the capsular bag.

WARNINGS

Physicians considering lens implantation under any of the conditions described in the Directions for Use labeling should weigh the potential risk/benefit ratio prior to implanting a lens. These conditions include: patients with recurrent severe anterior or posterior segment inflammation or uveitis, patients in whom the intraocular lens may affect the ability to observe, diagnose or treat posterior segment diseases, surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled positive pressure or significant vitreous prolapse or loss), a distorted eye due to previous trauma or developmental defect in which appropriate support of the IOL is not possible, circumstances that would result in damage to the endothelium during implantation, suspected microbial infection, patients in whom neither the posterior capsule nor the zonules are intact enough to provide support for the IOL, since the clinical study of parent lens model 911A was conducted with the lens implanted in the capsular bag, there are insufficient clinical data to demonstrate the safety and efficacy for placement in the ciliary sulcus, children under the age of 2 years are not suitable candidates for intraocular lenses, the use of silicone lenses in patients with current vitreoretinal disease or those who are at high risk for future vitreoretinal disease that may require silicone oil as part of therapy should be reconsidered. Johnson & Johnson Surgical Vision IOLs are single-use medical devices that are labeled with instructions for use and handling to minimize exposure to conditions that may compromise the product, patient, or the user. The reuse/resterilization/reprocessing of JJSV single-use medical devices may result in physical damage to the medical device, failure of the medical device to perform as intended, and patient illness or injury due to infection, inflammation, and/or illness due to product contamination, transmission of infection, and lack of product sterility.

PRECAUTIONS

Do not resterilize the lens as this can produce undesirable side effects. Do not soak or rinse the intraocular lens with any solution other than sterile balanced salt solution or sterile normal saline. Do not store the lens in direct sunlight or at a temperature greater than 45°C. Do not autoclave the intraocular lens. Avoid exposure to volatile chemicals. Do not reuse the lens.

ADVERSE EVENTS

The most frequently reported adverse event that occurred during the clinical trials of the parent lens models for the TECNIS® CL intraocular lens was corneal edema (upper and lower corneal edema), which occurred at a combined rate of 10.9%. The second most frequent adverse event was iritis, which occurred at a rate of 7.9%. Macular edema was the third most frequently reported adverse event, which occurred at a rate of 3.8%. Other reported reactions occurring in less than 2% of patients were hyphema, secondary glaucoma, cyclitic membrane, vitritis, surgical intervention (penetrating keratoplasty, lens replacement, and lens removal, lens repositioning, wound leak repair, and focal laser therapy), corneal decompensation and endophthalmitis.

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE ONE SERIES ULTRATM CARTRIDGE IMPLANTATION SYSTEM

Rx Only

INDICATIONS

The DK7786 handpiece with the One Series UltraTM cartridge implantation system is used to fold and assist in inserting TECNIS® 1-Piece intraocular lenses (IOL), ONLY into the capsular bag.

CONTRAINDICATIONS

Do not use the handpiece if the rod tip appears nicked or damaged in any way.

WARNINGS

The DK7786 handpiece with the One Series UltraTM cartridge implantation system should only be used with TECNIS® 1-Piece IOLs. Do not use if the cartridge tip is cracked or split prior to implantation. Never release the plunger until the optic body has been completely released from the cartridge tube. The lens and cartridge should be discarded if the lens has been folded within the cartridge for more than 5 minutes. If the IOL is not properly placed in the cartridge, the IOL may be damaged and/or implanted upside down. Do not attempt to modify or alter this device or any of the components, as this can significantly affect the function and/or structural integrity of the design. Use of methylcellulose viscoelastics is not recommended as they have not been validated with this implantation system. Do not implant lens if rod tip becomes jammed in the cartridge.

PRECAUTIONS

The use of viscoelastics is required when loading the IOL into the cartridge. For optimal performance use the HEALON® Family of Viscoelastics. Do not use balanced salt solution. The combination of low operating room temperatures and high IOL diopter powers may require a slower delivery. Do not use if any component of this implantation system has been dropped or inadvertently struck while outside of the shipping case. Do not store the cartridges at temperatures under 41°F (5°C) or over 86°F (30°C).

ATTENTION

Reference the labeling for a complete listing of Indications and Important Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE VERITASTM Vision System

CAUTION

Federal law (USA) restricts this device to sale by or on the order of a physician

INDICATIONS FOR USE / INTENDED USES

The VERITASTM Vision System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.

CONTRAINDICATIONS

Any pre-existing patient condition/s that the health care provider determines to be a contraindication to cataract surgery

UNDESIRABLE SIDE EFFECTS

Complications that may be associated with the VERITASTM Vision System include

  • corneal burn
  • infection/inflammation
  • corneal edema
  • broken capsule

PRECAUTIONS

Once you have set the system up and you have verified that all the functions are operating properly, you are almost ready to use your system. Read the following safety precautions carefully before using the system in surgery.

1. Do not use extension cords with your system.
2. Do not overload your electrical receptacle (outlet).
3. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures which can result in a fire hazard.
4. Do not try to move the system cart on deep pile carpets or over objects on the floor, such as cables and power cords.
5. Take care not to trip over power and foot pedal cords.
6. Do not try to lift the system console.
7. Do not place the instrument on uneven or sloped surfaces.
8. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by JJSV.
9. Do not operate the system in a condensing environment (over 95% relative humidity). Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only:
  • sterile tubing packs
  • sterile irrigation fluid
  • sterile handpieces
10. Wrap the excess power cord neatly around the cord wrap on the back of the console.
11. Use caution when you use handpieces with sharp edges or pointed tips.
12. Always replace the tubing pack and the balanced salt solution bottle between cases.
13. Use extreme caution when you lower or raise the balanced salt solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure.
14. If you do not properly prime the I/A tubing, errors can occur.
15. Care should be taken to avoid abrasion of tissues during phacoemulsification
16. It is very important that the electrical connectors on the handpieces are completely dry before you attach the handpiece to the system receptacles.
17. The phaco handpiece is a very delicate instrument and you must handle the handpiece with EXTREME care.
18. The ultrasonic titanium phaco tip must never touch any solid material while in use.
19. Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling.
20. Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye.
21. Failure to properly attach the tubing to the vacuum source or pressure source can affect the vitrectomy cutter operation.
22. You must check the diathermy cable periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance.
23. During surgery, the diathermy output power must be as low as possible for the intended purpose. JJSV recommends the 30% setting to start.
24. You must position the diathermy cable in such a way that the cable avoids contact with the patient or other leads. When you use diathermy, grounded or ungrounded metal parts must not come in contact with the patient.
25. For proper operation of the diathermy, replace the handpiece with the same type.
26. Do not exceed the maximum weight of two 500 ml balanced salt solution bottles on the IV pole bottle holder.
27. Do not attempt to carry the foot pedal by the heel when the heel insert is attached. The heel insert could become loose causing the foot pedal to drop.
28. Do not place the foot pedal on a wet surface.
29.Securely attach plugs, handpiece cables, and other connectors.
30. Do not have any other Bluetooth® devices in the same area as the remote and the console (other remote controls, foot pedals, cell phones, or headsets, for example) as the pairing operation will fail. The software can detect a maximum of nine (9) devices.
31. Never attempt to straighten a bent phaco ultrasonic tip. This might produce a broken tip when you apply ultrasound.
32. Perform functional checks of the system before first use of the day.
33. If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly.
34. Only use the JJSV specified replacement battery in the Advanced Linear Pedal to ensure correct system performance.
35. This equipment has been tested for radiated RF immunity only at the frequencies and levels listed in the section “Electromagnetic Compatibility/Disturbances” in the Operator Manual which are the types of emitters expected to be found in the professional healthcare environment. Use of nearby emitters at other frequencies could result in improper operation and may cause the system to enter a safe state as defined in the ““Errors” section of the Operator’s Manual. It may be necessary to take mitigation measures such as reorienting or relocating the VERITASTM Vision System or shielding the location.
36. The VERITASTM Vision System EMISSIONS characteristics make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

WARNINGS

1. All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device.
2. Do not modify the VERITASTM Vision System.
3. The system comes equipped with a 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician.
4. For 120V units, grounding reliability can only be achieved when this equipment is connected to a receptacle marked “Hospital Grade” or bearing a green dot.
5. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
6. Ensure the balanced salt solution bottle is at or above the eye level of the patient.
7. The surgical staff must monitor the balanced salt solution bottle height and fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in:
  • Inadvertent chamber shallowing or collapse
  • Aspiration or abrasion of the iris or other tissue
  • An ultrasonic wound heating commonly called wound burn (extreme case)
8. Do not attempt to use the system if the system fails to perform properly as stated in this manual.
9. Use caution when you extend, retract, or swivel the Mayo tray articulating arm. Stay clear of the hinged hardware.
10. Do not modify the pole height or manually force the pole height because this could cause incorrect indication of bottle height and patient injury.
11. Please note that when Cont. Irr. Auto-Off is enabled, a significantly large wound leakage or air bubbles in the tubing lines may affect the feature.
12. Bottles are the only irrigation source specified for use with the VERITASTM Advanced Infusion Tubing Pack. Using the VERITASTM Advanced Infusion Tubing Pack with a bag as the irrigation source could result in a lower irrigation pressure than what is reported by the system.
13. Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse.
14. Place monitoring electrodes or other types of equipment as far from those of the VERITASTM Vision System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes.
15. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient.
16. The output power selected must be as low as possible for the intended purpose.
17. This system complies with IEC 60601-1-2 4th edition for Electromagnetic Disturbances. It is still possible that disturbances produced by the operation of this High Frequency (HF) Surgical Equipment may adversely influence the operation of other electronic equipment.
18. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate.
  • The unit does not contain any neutral electrode.
  • The diathermy output is bipolar.
  • JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis.
19. Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration.
20. Hazardous electrical output. This equipment is for use only by qualified personnel.
21. If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call JJSV customer service to order a new cord.
22. Disconnect the power before you service the equipment.
23. Remove the power cord from the power outlet when the equipment is not in use.
24. Do not use the system in the presence of any of the following as a fire can result:
  • flammable anesthetics
  • other flammable gases
  • flammable fluids
  • flammable objects
  • oxidizing agents
25. Ensure the patient does not have a cardiac pacemaker or other active implant as this unit might interfere with any cardiac pacemaker; therefore, obtain qualified advice prior to such use.
26. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose.
27. Use proper handling and disposal methods for biohazards when you dispose of the tubing pack, Mayo tray drape, and monitor drape.
28. Ensure the tubing pack drain bag does not over-fill. The maximum capacity of the bag is 600 cc. Do not obstruct the power outlet so you can readily remove the power cord.
29. To prevent the risk of fire or damage to the instrument, replace the fuses with the exact type and rating (check the voltage sticker on the back panel of the system to confirm your system voltage).
30. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use. Only use the system within the stated relative humidity conditions.
31. You do not need to use a NEUTRAL ELECTRODE with this High Frequency (HF) Surgical Equipment.
32. Failure of this High Frequency (HF) Surgical Equipment could result in an unintended increase of output power.
33. Do not replace the foot pedal battery while in use with a patient.
34. Do not replace the remote control battery while in use with a patient.
35. Do not try to replace the batteries for the Advanced Control Pedal. Call your JJSV technical service representative to replace the batteries.
36. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use.
37. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury.
38. Do not have the handpiece tip in the eye of the patient when you prime and tune the handpiece.
39. Do not use non-JJSV approved products with the VERITASTM Vision System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.
40. Use tips and sleeves that are designed to work together. Using improperly matching tip/sleeve combinations can result in insufficient fluid flow.
41. Do not use the sleeves beyond their useful life. Using sleeves beyond their useful life can result in insufficient fluid flow or debris in the eye.
42. Inspect batteries for damage before installation. Do not install damaged batteries. Installing damaged batteries could result in a fire.
43. Avoid balanced salt solution free flow conditions. Balanced salt solution free flow can result in a slip hazard.
44. The Advanced Infusion feature must only be used with bottles and is not to be used with bags. Using the Advanced Infusion feature with a bag may result in lower than expected irrigation pressure.
45. Do not use the ultrasonic tip beyond its specified useful life. Using the ultrasonic tip beyond its specified useful life may result in:
  • exfoliation of the tip leaving debris in the eye
  • reduced cutting capability, which may increase time required for surgery
  • insufficient flow of fluid
46. The VERITASTM Swivel handpiece is an inseparable assembly. The user must not attempt to disassemble the swivel joint.
47. If the sterile packaging for a single-use accessory is damaged, notify JJSV. Do not use the accessory as sterility cannot be assured.
48. All tubing packs are single-use. Reusing a single-use device can cause bodily fluids from one patient to enter the eye of another patient. This can lead to medical conditions including: Toxic Anterior Segment Syndrome (TASS), Chemosis, Conjunctivitis Microbial, Endophthalmitis, Infectious Keratitis, Anterior Uveitis, and Keratoconjunctivitis.
49. Do not charge the Foot Pedal in the patient environment. Do not come in contact with patient when touching the device under charge.
50. When using Advanced Infusion, the effective bottle height cannot go below 30cm without re priming and selecting the Advanced Fluidics program.
51. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the VERITASTM Vision System or shielding the location.
52. The VERITASTM Vision System needs special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual.
53. Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VERITASTM Vision System, including cables specified by JJSV. Otherwise, degradation of the performance of this equipment could result.
54. The use of accessories, transducers and cables other than those specified by JJSV, may result in increased electromagnetic EMISSIONS or decreased electromagnetic IMMUNITY of the VERITASTM Vision System.
55. The USB port should only be used for the data transfer purposes described in this manual. It should not be used to charge devices or connect peripheral devices. The VERITASTM Vision System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the VERITASTM Vision System should be observed to verify normal operation in the configuration in which it will be used.
56. Do not replace the foot pedal battery when the pedal is attached to a power source.
57. Electrostatic Discharge (ESD) may disrupt the function and operation of the VERITASTM Vision System and cause the system to go into a safe state and display an error message. If an error message occurs, follow the on-screen troubleshooting, or refer to the “Troubleshooting” section of the Operator’s manual. If the system requires restarting to resolve the error, be sure to remove the handpiece from the eye prior to shutting down the system.
58. The VERITASTM Vision System may be interfered with by other equipment, even if that other equipment complies with regulatory emission requirements such as the International Special Committee on Radio Interference (CISPR).
59. Electromagnetic Disturbances from RFID readers are unlikely to affect the VERITASTM Vision System; however antennas from RFID readers should be kept more than 2.5 cm (1 inch) from the system.
60. Inadvertent activation of functions that are intended for priming or tuning handpieces while the handpiece is in the eye can create a hazardous situation that could result in patient injury.
61. Danger of ignition of endogenous gases (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of High Frequency (HF) Surgical Equipment).
62. Ensure the maximum capacity of the drain container is not exceeded as this could cause a hazardous situation to the patient.
63. The ophthalmic irrigation solution source shall be at or above the patient's eye level.
64. Never intentionally modify handpieces or tips (e.g., do not bend, cut, or engrave them) as they could break or malfunction.
65. Use caution when using clamps on a tubing set.
66. Use only recommended tubing set(s).
67. Do not touch an activated ultrasonic handpiece tip, as injuries could occur.
68. Use of accessories, transducers, and cables other than those provided with the VERITASTM Vision System could cause increased electromagnetic emissions or decreased electromagnetic immunity of this equipment, resulting in improper operation.
69. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the VERITASTM Vision System, including cables specified by JJSV. Otherwise, degradation of the performance of this equipment could result.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
FUSION® DUAL PUMP PACK (OPO73)

Rx Only

INDICATIONS

The DUAL PUMP Pack contains the tubing sets and manifold and is intended to perform irrigation and aspiration during anterior segment cataract surgery. It is used with the WHITESTAR SIGNATURE® or  WHITESTAR SIGNATURE® PRO Systems (“WHITESTAR SIGNATURE®  System(s)”). The DUAL PUMP Pack is sterilized using ethylene oxide and is designed for single use only.

WARNINGS

Single use only. Do not re-sterilize, reprocess, or reuse this device.

PRECAUTIONS

Do not use product after its expiration date marked on product’s packaging labels. Contents are sterile when product tray is sealed with lid and undamaged. Do not resterilize and do not reuse. Only use this DUAL PUMP Pack with the
WHITESTAR SIGNATURE® Systems. Overall system performance may be impaired when used in combination with non-Johnson & Johnson Surgical Vision products. If product performance becomes compromised during use, discontinue use and perform the appropriate tests as detailed in the Operator’s Manual. If results are not satisfactory, replace the DUAL PUMP Pack according to instructions defined in the Operator’s Manual.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR MULTIPLE-USE PACK (OPO85)

Rx Only

 

INDICATIONS

The OPO85 is used with the COMPACT INTUITIVTM System. The OPO85 is sterilized using Ethylene Oxide and is designed for use up to 20 times. Following the first use, the user then follows cleaning and sterilization instructions specified below for up to 19 additional cleaning/sterilization cycles for a total of 20 uses when used according to the Instructions for Use.

 

CAUTION

Do not sterilize the OPO85 prior to performing the cleaning procedure described in OPO85 Directions for Use.

 

WARNINGS

Sterility assurance is the responsibility of the user. The use of gas resterilization is not recommended. If the OPO85 is received in an unsatisfactory condition, please contact your local JJSV Sales Office immediately. Each OPO85 is identified by a lot number and this should be included in any correspondence or discussions.

 

PRECAUTIONS

Contents are sterile when tray is sealed and undamaged. Only use the OPO85 with the COMPACT INTUITIV System. Overall system performance may be impaired when used in combination with JJSV products. If product performance becomes compromised during use; discontinue use and perform the appropriate steps as detailed in the Operator’s Manual. If results are not satisfactory, replace the OPO85 according to instructions defined in the Operator’s Manual. Improper/inadequate cleaning may result in particulate matter adhering to the internal surfaces of the tubing and MANIFOLD. As a result, the functionality of OPO85 may become compromised. After a maximum of 20 uses (19 reuses), the OPO85 must be discarded. The OPO85 has not been tested past 20 uses. Always ensure proper COMPACT INTUITIV System settings are used with the OPO85. Only use approved OPO85 accessories.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the
CATALYS® Precision Laser System

 
Rx Only

Indications

The CATALYS® Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Contraindications

The CATALYS® System is contraindicated in patients with corneal ring and/or inlay implants, severe corneal opacities, corneal abnormalities, significant corneal edema or diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule, patients younger than 22 years of age, descemetocele with impending corneal rupture, and any contraindications to cataract surgery. 

Warnings

Prior to INTEGRAL GUIDANCE System imaging and laser treatment, the suction ring must be completely filled with sterile buffered saline solution. If any air bubbles and/or a meniscus appear on the video image before treatment, do not initiate laser treatment. Before initiating laser treatment, inspect images created from the OCT data, surface fits, and overlaid pattern in both axial and sagittal views, and review the treatment parameters on the Final Review Screen for accuracy. Safety margins for all incisions are preserved only if Custom Fit Adjustments to ocular surface(s) are applied in accordance with the instructions for use. Purposeful misuse of the Custom Fit Adjustment to ocular surfaces can result in patient injury and complication(s), and therefore must be avoided. Standard continuous curvilinear capsulorrhexis (CCC) surgical technique must be used for surgical removal of the capsulotomy disc. The use of improper capsulotomy disc removal technique may potentially cause or contribute to anterior capsule tear and/or a noncircular, irregularly shaped capsulotomy. Verify that the suction ring is correctly connected to the disposable lens component of the LIQUID OPTICS Interface during the initial patient docking procedure. 

Precautions

The CATALYS® System has not been adequately evaluated in patients with a cataract greater than Grade 4 (via LOCS III); therefore no conclusions regarding either the safety or effectiveness are presently available. Cataract surgery may be more difficult in patients with an axial length less than 22 mm or greater than 26 mm, and/or an anterior chamber depth less than 2.5 mm due to anatomical restrictions. Use caution when treating patients who may be taking medications such as alpha blockers (e.g. Flomax) as these medications may be related to Intraoperative Floppy Iris Syndrome (IFIS); this condition may include poor preoperative dilation, iris billowing and prolapse, and progress intraoperative miosis. These conditions may require modification of surgical technique such as the utilization of iris hooks, iris dilator rings, or viscoelastic substances. Surgical removal of the cataract more than 30 minutes after the laser capsulotomy and laser lens fragmentation has not been clinically evaluated. The clinical effects of delaying surgical removal more than 30 minutes after laser anterior capsulotomy and laser lens fragmentation are unknown. The LIQUID OPTICS Interface is intended for single patient use only. Full-thickness corneal cuts or incisions should be performed with instruments and supplies on standby, to seal the eye in case of anterior chamber collapse or fluid leakage. Patients who will undergo full-thickness corneal incisions with the CATALYS® System should be given the same standard surgical preparation as used for patients undergoing cataract surgery for the removal of the crystalline lens. During intraocular surgery on patients who have undergone full-thickness corneal incisions with the CATALYS® System, care should be taken if an eyelid speculum is used, in order to limit pressure from the speculum onto the open eye. Patients who will be transported between the creation of a full-thickness corneal incision and the completion of intraocular surgery should have their eye covered with a sterile rigid eye shield, in order to avoid inadvertent eye injury during transport. Patients must be able to lie flat and motionless in a supine position and able to tolerate local or topical anesthesia. 

Adverse Effects

Complications associated with the CATALYS® System include mild Petechiae and subconjunctival hemorrhage due to vacuum pressure of the LIQUID OPTICS Interface Suction ring. Potential complications and adverse events generally associated with the performance of capsulotomy and lens fragmentation, or creation of a partial-thickness or full-thickness cut or incision of the cornea, include: Acute corneal clouding, age- related macular degeneration, amaurosis, anterior and/or posterior capsule tear/rupture, astigmatism, capsulorrhexis notch during phacoemulsification, capsulotomy/lens fragmentation or cut/incision decentration, cells in anterior chamber, choroidal effusion or hemorrhage, conjunctival hyperemia/injection/erythema/chemosis, conjunctivitis (allergic/viral), corneal abrasion/depithelization/epithelial defect, corneal edema, cystoid macula edema, Descemet’s detachment, decentered or dislocated intraocular lens implant, diplopia, dropped or retained lens, dry eye/superficial punctate keratitis, edema, elevated intraocular pressure, endothelial decompensation, floaters, glaucoma, halo, inflammation, incomplete capsulotomy, intraoperative floppy iris syndrome, iris atrophy/extrusion, light flashes, meibomitis, ocular discomfort (e.g., pain, irritation, scratchiness, itching, foreign body sensation), ocular trauma, petechiae, photophobia, pigment changes/pigment in corneal endothelium/foveal region, pingueculitis, posterior capsule opacification, posterior capsule rupture, posterior vitreous detachment, posteriorly dislocated lens material, pupillary contraction, red blood cells in the anterior chamber (not hyphema), residual cortex, retained lens fragments, retinal detachment or hemorrhage, scar in Descemet’s membrane, shallowing or collapsing of the anterior chamber, scoring of the posterior corneal surface, snailtrack on endothelium, steroid rebound effect, striae in Descemet’s, subconjunctival hemorrhage, thermal injury to adjacent eye tissues, toxic anterior shock syndrome, vitreous in the anterior chamber, vitreous band or loss, wound dehiscence, wound or incision leak, zonular dehiscence.

Caution

Federal law (USA) restricts this device to sale by or on the order of a physician. The system should be used only by qualified physicians who have extensive knowledge of the use of this device and have been trained and certified.

Attention

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
WHITESTAR SIGNATURE® PRO SYSTEM

Rx Only

INDICATIONS

The WHITESTAR SIGNATURE® PRO is a modular ophthalmic microsurgical system that facilitates anterior segment (cataract) surgery. The modular design allows the users to configure the system to meet their surgical requirements.

WARNINGS

1. All personnel who might operate this equipment must read and understand the instructions in this manual before they use the system. Failure to do so might result in the improper operation of the system. Only a trained licensed physician can use this device.
2. Do not modify the WHITESTAR SIGNATURE® PRO System.
3. The system comes equipped with a 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin.
4. When using peristaltic, make sure that the balanced salt solution bottle is at or above the eye level of the patient.
5. The surgical staff must monitor the balanced salt solution bottle height and fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in:
  • Inadvertent chamber shallowing or collapse
  • Aspiration or abrasion of the iris or other tissue
  • An ultrasonic wound heating commonly called wound burn (extreme case)
6. DO NOT attempt to use the system if the system fails to perform properly as stated in this manual.
7. DO NOT use the system in the presence of any of the following as a fire can result:
  • flammable anesthetics
  • other flammable gases
  • flammable fluids
  • flammable objects
  • oxidizing agents
8. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use.
9. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. Johnson & Johnson Surgical Vision, Inc. (JJSV) recommends the use of an antistatic mat for this purpose.
10. Use proper handling and disposal methods for biohazards when you dispose of the fluidics pack, Mayo tray drape, and monitor drape.
11. Make sure that the fluidics pack drain bag does not over-fill. The maximum capacity of the bag is 750 cc.
12. Use caution when you extend, retract, or swivel the Mayo tray articulating arm. Stay clear of the hinged hardware.
13. Do not modify the pole height or manually force the pole height because this could cause incorrect indication of bottle height and patient injury.
14. Place monitoring electrodes or other types of equipment as far from those of the WHITESTAR SIGNATURE® PRO System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes.
15. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient.
16. The output power selected must be as low as possible for the intended purpose.
17. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment.
18. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis.
19. Risk of burns and fire. Do not use the system near conductive materials such as metal bed parts, inner spring mattresses, or similar items. Replace electrode cables on evidence of deterioration.
20. Hazardous electrical output. This equipment is for use only by qualified personnel.
21. Disconnect the power before you service the equipment.
22. Remove the power cord from the power outlet when the equipment is not in use.
23. Do not obstruct the power outlet so you can readily remove the power cord.
24. Not recommended for use in condensing environments. If exposed to a condensing environment, allow the system to equilibrate to typical operating room conditions prior to use.
25. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT.
26. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power.
27. DO NOT try to replace the batteries for the wireless remote control, the Advanced Control Pedal. Call your JJSV technical service representative to replace the batteries.
28. DO NOT try to replace the wireless remote control batteries. Call your JJSV technical service representative to replace the batteries.
29. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use.
30. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury.
31. Do not have the handpiece tip in the eye of the patient when you prime and tune the handpiece.
32. Do not use non-JJSV approved products with the WHITESTAR SIGNATURE® PRO System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.
33. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the WHITESTAR SIGNATURE® PRO System or shielding the location.
34. WHITESTAR SIGNATURE® PRO System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual.
35. Portable and mobile RF communications equipment can affect WHITESTAR SIGNATURE® PRO System.
36. The use of accessories, transducers and cables other than those specified by JJSV, may result in increased EMISSIONS or decreased IMMUNITY of the WHITESTAR SIGNATURE® PRO System.
37. The WHITESTAR SIGNATURE® PRO System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the WHITESTAR SIGNATURE® PRO System should be observed to verify normal operation in the configuration in which it will be used.
38. Do not replace the Advanced Linear Pedal (ALP) battery when the pedal is attached to a power source.
39. This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the WHITESTAR SIGNATURE® PRO System or shielding the location.
40. WHITESTAR SIGNATURE® PRO System may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements.
41. If you do not properly prime the I/A tubing, errors can occur.
 

SAFETY PRECAUTIONS

Read the following safety precautions and warnings carefully before you use the system in surgery. Do not use extension cords with your system. Do not overload your electrical receptacle (outlet). If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call JJSV customer service to order a new cord. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation. Do not block the openings; as heat build-up can cause system failures, which can result in a fire hazard. Do not try to move the system cart on deep pile carpets or over objects on the floor such as cables and power cords. Take care not to trip over power and foot pedal cords. Do not try to lift the system console. Do not place the instrument on uneven or sloped surfaces. Only use disposables, accessories, or other surgical instruments designed for this system. For optimum performance of the system and safety, use only parts recommended by JJSV. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup. To protect the patient from contaminated fluids or handpieces, use only sterile tubing packs, sterile irrigation fluid, and sterile handpieces. Wrap the excess power cord neatly around the cord wrap on the back of the console. Use caution when you use handpieces with sharp edges or pointed tips. Always replace the tubing pack and the balanced salt solution bottle between cases.

CAUTIONS

Never attempt to straighten a bent needle. This might produce a broken tip when you apply ultrasound. Do not activate the phaco handpiece and vitrectomy cutter with the tip in the air. Exposure of the tip to air drastically reduces the useful life of the handpiece. If you introduce power to the phaco handpiece or vitrectomy cutter, the tip must be in a test chamber filled with balanced salt solution, in a container of balanced salt solution, or in the patient’s eye. If you do not hear a tone when you press the foot pedal and volume adjustment is unsuccessful, the mode is not functioning properly.

Federal law (USA) restricts this device to sale by or on the order of a physician.

WARNINGS FOR CASA

System passwords are set only by JJSV Service personnel. Be sure to keep system passwords in a secure location. The connection to a WHITESTAR SIGNATURE® PRO only provides a means to retrieve files from the System, and does not provide the means to send files back to the System. The CASA application will display a notification when the total storage capacity of the iPad device is less than 2 GB. It is important to note there is no patient data on the WHITESTAR SIGNATURE® PRO, and no patient data is imported to the CASA application. Care must be taken when removing data from the iPad device. If the data is removed without having exported it in an email, there will be no way to import the data back into the iPad device.

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
COMPACT INTUITIVTM SYSTEM

Rx Only

INDICATIONS

The COMPACT INTUITIVTM System is an AC-powered device with a fragmenting needle for cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Single-Use Pack is used with the COMPACT INTUITIVTM System. The Single-Use Pack is sterilized using Ethylene Oxide and is designed for single use only.

 

READ THE FOLLOWING SAFETY PRECAUTIONS AND WARNINGS CAREFULLY BEFORE YOU USE THE SYSTEM IN SURGERY

  1. Do not use extension cords with your machine.
  2. Do not overload your AC electrical outlet.
  3. If there is damage to the cord or the plug, do not use the instrument. A damaged cable can cause an electric shock to the user or a fire hazard to the system. Call Johnson & Johnson Surgical Vision, Inc. customer service to order a new cord.
  4. Do not block the openings as heat build-up can cause system failures that can result in a fire hazard. The instrument has ventilation openings at the rear of the console to allow ambient air intake and the release of heat generated during operation.
  5. Do not block the air fans on the bottom of the console as heat build-up can cause system failures which can result in a fire hazard.
  6. Do not try to roll the system cart on carpets or over objects on the floor such as cables and power cords.
  7. Take care not to trip over the power cords and the foot pedal cords.
  8. Do not place the instrument on uneven or sloped surfaces.
  9. Only use disposables, accessories, or other surgical instruments designed for this system. Use only parts recommended by Johnson & Johnson Surgical Vision, Inc.to achieve the optimum performance and the safety of the system.
  10. Do not operate the system in a condensing environment. Take care to protect the instrument from fluid sprays or fluid buildup.
  11. Do not exceed maximum weight of 25 pounds (11.25 Kg) on the Programmable IV Pole bottle holder.
  12. Do not use more than one IV pole extender with the IV pole.
  13. If there is no IV pole attached to the system, hang the irrigation fluid container at least 77 cm from the patient’s eye.
  14. To protect the patient from contaminated fluids or handpieces, use only:
    • sterile tubing sets
    • sterile irrigation fluid
    • sterile handpieces
  15. Use caution when handling handpiece with sharp edges or pointed tips.
  16. Wrap the excess power cord neatly around the cord wrap on the back of the IV pole or cart.
  17. Always replace the Single-Use Pack and irrigation solution bottle between surgical cases.

 

Changing Irrigation

Use extreme caution when you lower or raise the irrigation solution bottle to decrease fluid flow or increase fluid flow, and fluid pressure. If you lower the bottle too much it can cause the anterior chamber to collapse or to become too shallow; take care to avoid abrasion of tissues during phacoemulsification. If you raise the bottle too high it can cause the anterior chamber to deepen. Note: Use a new bottle of irrigation solution at the start of each case.

 

Phacoemulsification Without Adequate Irrigation

Operating phacoemulsification without an adequate irrigation flow can result in an elevated temperature of the tip and subsequent damage to the eye tissue or could cause the chamber to collapse. Confirm that there is irrigation flow before you initiate phacoemulsification. A tight wound or the angle of the needle next to the wound can also constrict the irrigation flow. Pinching of the coaxial irrigation sleeve assembly on the needle of the phaco handpiece causes the constriction.

 

Power Failure During Surgery

If there is a loss of power during a procedure, you need to:

  • Withdraw the handpiece from the eye; and
  • Release the foot pedal to position 0.

When power is restored:

  • Select Prime/Tune to reprime the fluids and tune the phaco handpiece. Use Bypass to reduce the length of prime time.
  • Select the mode that was in use when the system lost power (Phaco, IA, Vitrectomy, or Diathermy).

 

Connecting Handpieces

It is very important that the electrical connectors on the handpieces are completely dry prior to connecting them to the system receptacles. You may receive a “Phaco Handpiece Error” message if the connector is wet.

 

Handling the Phaco Handpiece

The phaco handpiece is a very delicate instrument and you must handle the handpiece with EXTREME care. If you drop the handpiece or the handpiece receives any other significant impact, the handpiece might not work properly. The ultrasonic titanium phaco tip must never touch any solid material while in use. Always clear the handpiece of fluid immediately following surgery. See cleaning instructions in Chapter 7 "Care and Cleaning". Handpieces can be extremely hot immediately after sterilization. Use care and caution when handling.

 

Phaco and Vitrectomy Operation

Do not activate the Phaco and Vitrectomy handpieces with the tips in air as this reduces the useful life of the handpiece and the cutter. When introducing power to the Phaco or Vitrectomy handpieces, the tips should be in one of the following:

  • a test chamber filled with irrigating solution,
  • a container of irrigating solution, or
  • the patient’s eye.

 

Vitrectomy

Failure to properly attach the tubing to the appropriate vacuum source or pressure source affects the vitrectomy handpiece operation. Be sure to read the handpiece package insert for correct assembly procedures and connection procedures.

 

Diathermy

When you select the Diathermy mode, you hear a tone or a voice. Also, you hear an audible tone when you apply diathermy power. You must check the diathermy cable periodically for damage. If the cable shows signs of damage, replace the cable immediately with the same type of cable. Use of other types of cables can affect the diathermy performance. During surgery, the diathermy output power should be as low as possible for the intended purpose. Johnson & Johnson Surgical Vision, Inc. recommends 30% setting to start. The patient should not come into contact with ungrounded metal parts when using diathermy. Position the diathermy cable in such a way that the cable avoids contact with the patient or other leads. For proper operation of the diathermy, replace the handpiece with the same type.

 

Power IV Pole

Do not exceed maximum weight of 25 pounds (11.25 Kg) on the IV pole bottle holder.

 

Foot Pedal

Never handle the foot pedal by its power cord.

Do not place the foot pedal on a wet surface.

 

WARNINGS

All personnel should read and understand the instructions in the 
COMPACT INTUITIVTM System operator’s manual before they use the system. Failure to do so may result in the improper operation of the system. Only a trained and licensed physician is to use this device. The system comes equipped with a 3-prong power plug which you must plug into an outlet with a ground receptacle. If the plug does not fit the outlet, contact an electrician. DO NOT modify or remove the ground pin. The surgical staff must monitor the irrigation solution bottle height and the fluid level at all times. A low bottle or empty bottle affects the fluid balance and the intraocular pressure (IOP) while aspirating. Low bottle height or low or empty bottle fluid level can result in: inadvertent chamber shallowing or collapse, aspiration or abrasion of the iris or other eye tissue, an ultrasonic wound heating commonly called wound burn (extreme case). DO NOT attempt to use the system if it fails to perform properly as stated in this manual. DO NOT use the system in the presence of any of the following as a fire can result: flammable anesthetics, other flammable gases, flammable fluids, flammable objects, oxidizing agents. Make sure that the patient does not have a cardiac pacemaker as this unit might interfere with any cardiac pacemaker; therefore obtain qualified advice prior to such use. The patient must not come into contact with grounded metal parts or metal parts that have appreciable capacitance to ground. JJSV recommends the use of an antistatic mat for this purpose. Use proper handling and disposal methods for biohazards when you dispose of the Single-Use Pack, Mayo stand cover, and monitor cover. Follow good operating room procedures to prevent injury or contamination. Use caution when you extend, retract, or swivel the Mayo stand articulating arm. Stay clear of the hinged hardware. Make sure that you unlock the wheels before you move the cart. Make sure that the wheels move freely when moving the cart. Place monitoring electrodes or other types of equipment as far from those of the
 COMPACT INTUITIVTM System as possible. JJSV recommends high current limiting devices for the protection of such systems. Do not use needle monitoring electrodes. Keep the diathermy cord away from the patient and other handpieces or leads (for example, monitoring electrodes). Keep unused ACTIVE ELECTRODES away from the patient. The output power selected should be as low as possible for the intended purpose. This unit complies with all Electromagnetic Interference (EMI) standards and requirements. It is possible that interference provided by the operation of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT can adversely influence the operation of other electronic equipment. Do not have skin-to-skin contact on the patient. For example, between the arms and the torso. Insert dry gauze to avoid contact, as appropriate. Note: The unit does not contain any neutral electrode. Note: The diathermy output is bipolar. Note: JJSV recommends that you check the condition of all interconnecting and handpiece cables on a regular basis. Risk of burns and fire. Do not use near conductive materials such as metal bed parts, inner spring mattresses, and the like. Renew electrode cables on evidence of deterioration. Hazardous electrical output. This equipment is for use only by qualified personnel. Disconnect the power before you service the equipment. Remove the power cord from the power outlet when the equipment is not in use. Do not obstruct the power outlet so you can readily remove the power cord. Not recommended for use in condensing environment. If exposed to condensing environment, allow system to equilibrate to typical operating room conditions prior to use. You do not need to use a NEUTRAL ELECTRODE with this HIGH FREQUENCY (HF) SURGICAL EQUIPMENT. Failure of the HIGH FREQUENCY (HF) SURGICAL EQUIPMENT could result in an unintended increase of output power. Sterility assurance is the responsibility of the user. You must sterilize all non-sterile accessories prior to use. Prior to using any invasive portions of the handpiece assembly, examine under the microscope for any obvious damage, oxidation, or the presence of foreign material. You must note any questionable characteristics; use a backup handpiece for surgery. Use of contaminated or damaged system accessories can cause patient injury. Do not use non-JJSV approved products with the  COMPACT INTUITIVTM System, as this can affect overall system performance. JJSV cannot be responsible for system surgical performance if you use these products in surgery.

All third-party trademarks herein are the intellectual property of their respective owners.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
iFS® ADVANCED FEMTOSECOND LASER

INDICATIONS

The iFS® femtosecond laser is an ophthalmic surgical laser indicated for use in patients undergoing surgery or treatment requiring initial lamellar resection of the cornea, in treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, in treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal, In lamellar IEK and corneal harvesting; in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the corneal, in the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK, in treatment requiring the creation of corneal channels for placement/insertion of a corneal inlay device. 

 

CONTRAINDICATIONS

Lamellar resection for the creation of a corneal flap is contraindicated in the presence of corneal edema, corneal lesions, hypotony, glaucoma, existing corneal implant, or keratoconus.  IEK procedures and arcuate incisions are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, or corneal thickness requirements that are beyond the range of the system. Creation of corneal channels for placement/insertion of a corneal inlay device are contraindicated in the presence of any corneal opacity adequately dense to obscure visualization of the iris, descemetocele with impending corneal rupture, previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape, corneal thickness requirements that are beyond the range of the system, any previous incisional refractive corneal procedure, e.g. radial keratotomy, significant corneal neovascularization in the limbal area for a planned incision, previous history of corneal Herpes Simplex Keratitis, previous corneal transplant, any cataract, corneal edema, corneal lesions, hypotony, existing corneal implant, keratoconus or subjects with severe corneal thinning less than 450 microns.

 

PRECAUTIONS

A high level of surgical skill is required for these lasers. A surgeon should have successfully completed one or more training courses before attempting to create a corneal resection. The use of the iFS® Laser for IEK procedures or for arcuate incisions is not recommended for patients with severe corneal thinning, preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus. The use of the iFS® laser for creation of corneal channels for placement of a corneal inlay device is not recommended for patients with preexisting glaucoma, a history of steroid-responsive rise in intraocular pressure, preoperative intraocular pressure greater than 21 mm Hg in the operative eye, more than 1200 mm corneal thickness at the 9 mm peripheral zone, active intraocular inflammation, or active ocular infection or keratoconus.

 

ADVERSE EVENTS

Possible complications resulting from LASIK flap creation include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia, flap decentration, incomplete flap creation, flap tearing or incomplete lift-off, free cap, inflammation (e.g., diffuse lamellar keratitis, corneal infiltrates, or iritis), thin or thick flaps, or flap striae.  Transient light sensitivity syndrome (TLSS) and peripheral light spectrum (PLS) have been sporadically reported and may occur following LASIK flap creation. TLSS is characterized by symptoms of mild to severe light sensitivity that manifests between 2 and 6 weeks postoperatively. Patients experience no decrease in uncorrected or best spectacle-corrected visual acuity. The incidence of this sensitivity is observed in approximately 1% of patients who undergo flap creation with either laser. Patients respond to the use of hourly topical steroids and most report improvement within 1 week of treatment. PLS is a temporary phenomenon whereby patients report the perception of a spoke-like spectrum of light in the periphery of their vision. PLS has no clinical examination findings and no effect on visual acuity; however, the potential diffractive effects may be bothersome to some patients. Reported in only 0.03% of cases, the onset of symptoms occurs during the immediate postoperative period, and typically resolves within 3 months but may be slightly persistent in rare cases. The visual impact of PLS is clinically inconsequential for the vast majority of patients.  Arcuate incision complications include corneal edema/inflammation, corneal pain, epithelial ingrowth, epithelial defect, infection, photophobia or corneal endothelium perforation.  Creation of corneal channel for placement of a corneal inlay device complications include corneal edema, corneal pain, epithelial ingrowth, epithelial defect, infection, implant de-centration, incomplete inlay channel creation, corneal tearing or incomplete inlay channel dissection, photophobia, corneal inflammation, such as diffuse lamellar keratisis (DLK), corneal infiltrates, and iritis, and inlay channel bleeding.

 

WARNINGS

Check all treatment parameters for accuracy. The posterior depth should be programmed at least 125 microns above the corneal endothelium. Use of these laser systems allows laser surgical incisions up to 1200 µm deep. Setting the posterior depth too deep could result in injury to other ocular structures. Use caution when setting cut position and cut angle to avoid overlapping arcuate incisions. The applanation lens becomes etched by the laser during the side-cut procedures and must not be reused. Laser light will not effectively permeate an etched lens, and the precision of the laser will be altered. Patient interface disposables should not be reused or resterilized.

 

CAUTIONS

U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the
STAR S4 IR® Excimer Laser System and the
iDESIGN® Refractive Studio

INDICATIONS

The STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) to achieve monovision by the targeted retention of myopia (-1.25 to -2.00 D) in the non-dominant eye of presbyopic myopes: 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision, with myopic astigmatism, up to -6.00 D spherical equivalent as measured by iDESIGN® Refractive Studio, with cylinder up to -3.00 D, and a minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; with an agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio refraction as follows: Spherical equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.50 D; Cylinder Axis: If either the manifest cylinder entered into the iDESIGN® Refractive Studio or the
iDESIGN® Refractive Studio cylinder selected for treatment is less than 0.50 D, there is no requirement for axis tolerance. When both cylinders have a magnitude of at least 0.50 D, the axis tolerance is linearly reduced from 15º (0.5 D) to 7.5º (7.0 D or greater) based on the average magnitude of both cylinders. With documented evidence of a change in manifest refraction of no more than 0.50 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination; and with a successful preoperative trial of monovision or history of monovision experience. The STAR S4 IR® Excimer Laser System and
iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio
is indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) in patients: With hyperopia with and without astigmatism as measured by
iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio
up to +4.00 D spherical equivalent, with up to 2.00 D cylinder; with mixed astigmatism as measured by iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio where the magnitude of cylinder (1.0 D to 5.0 D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs; with myopia as measured by iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio up to -11.00 D spherical equivalent, with up to -5.00 D cylinder; with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Advanced WaveScan Studio System/iDESIGN® Refractive Studio refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D; Cylinder: Magnitude of the difference is less than or equal to 0.5 D; 18 years of age or older, and with refractive stability (a change of ≤1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).

 

CONTRAINDICATIONS

Wavefront-guided LASIK surgery is contraindicated in patients with collagen vascular, autoimmune or immunodeficiency diseases; in pregnant or nursing women; in patients with corneal abnormalities including signs of keratoconus, abnormal corneal topography, epithelial basement membrane disease (EBMD) and degenerations of the structure of the cornea; in patients with symptoms of significant dry eyes. If the patients have severely dry eyes, LASIK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing of the flap or interfere with the surface of the eye after surgery. It may result in poor vision after LASIK. In patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma; in patients with advanced glaucoma; in patients with uncontrolled diabetes; in patients with documented evidence of a change in manifest refraction of more than +0.5 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. in patients taking medications with ocular side effects. Examples are Isotretinoin (Accutane®) for acne treatment or Amiodarone hydrochloride (Cordarone®) for normalizing heart rhythm.

 

WARNING AND PRECAUTIONS

Wavefront-guided LASIK is not recommended in patients who have systemic diseases likely to affect wound healing, such as autoimmune connective tissue disease, diabetes or an immunocompromised status; have a history of Herpes simplex or Herpes zoster keratitis; have severe allergies or tendency rub their eyes often; have glaucoma, elevated IOP, ocular hypertension or being followed for possible glaucoma (glaucoma suspect); are taking the medication Isotretinoin (Accutane®); are taking antimetabolites for any medical conditions. To reduce the risk of corneal ectasia, the posterior 250 microns (μm) of corneal stroma should not be violated. Please refer to Operator’s Manual for a list of additional Precautions.

 

 

CAUTION

U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device.

 

ADVERSE EVENTS

Prior clinical study of monovision LASIK using the WaveScan WaveFront® System aberrometer, supports the safety and effectiveness of iDESIGN® driven Monovision LASIK Treatment. Please refer to Operator’s Manual for a list of Adverse Events and complications in clinical studies for Wavefront-guided Monovision in Presbyopic Patients with Low to Moderate Myopia and Wavefront-guided Myopic Astigmatism, Myopia, Mixed Astigmatism and Hyperopia.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION for the
STAR S4 IR® Excimer Laser System and the
iDESIGN® Refractive Studio for Wavefront-Guided Photorefractive Keratectomy (PRK)

INDICATIONS

The STAR S4 IR® Excimer Laser System and the iDESIGN® Refractive Studio is indicated for wavefront-guided photorefractive keratectomy (PRK) in patients: with myopia, with or without astigmatism, as measured by
iDESIGN® Refractive Studio System with spherical equivalent up to -8.00 D, and cylinder up to -3.00 D, with agreement between manifest refraction (adjusted for optical infinity) and iDESIGN® Refractive Studio System refraction as follows: Spherical Equivalent: Magnitude of the difference is less than 0.625 D, Cylinder: Magnitude of the difference is less than or equal to 0.5 D, in patients 18 years of age or older; with refractive stability (a change of ≤1.0 D in manifest refraction spherical equivalent for a minimum of 12 months prior to surgery), and with wavefront capture diameter of at least 4 mm.

 

CONTRAINDICATIONS

iDESIGN® System driven PRK surgery is contraindicated in patients with any type of active connective tissue disease or autoimmune disease, in patients with signs of keratoconus, abnormal corneal topography, and degenerations of the structure of the cornea, in patients whose corneal thickness would cause anticipated treatment would violate the posterior 250 microns (μm) of corneal stroma, in patients with uncontrolled diabetes, in patients with active eye infection or active inflammation, in patients with recent herpes eye infection or problems resulting from past infection, in patients with significant dry eyes. If the patients have severely dry eyes, PRK may increase the dryness. This may or may not go away. Severe eye dryness may delay healing or interfere with the surface of the eye after surgery. It may result in poor vision after PRK.

 

WARNING AND PRECAUTIONS

iDESIGN® System driven PRK surgery is not recommended in patients have systemic diseases that may affect wound healing, such as controlled autoimmune, or connective tissue disease, or controlled diabetes, have an immunocompromised status or take medications that may result in a weakened immune system such as antimetabolites for any medical conditions or affect wound healing such as Isotretinoin (Accutane®), have a history of Herpes simplex or Herpes zoster keratitis, have glaucoma, In patients with a cardiac pacemaker, implanted defibrillator or other implanted electronic device, have mild to moderate dry eye, have decreased vision in one eye (e.g., amblyopia). Surgeons are reminded that they should instruct the patient to fixate on the Patient Fixation LED during surgery with or without the use of the ActiveTrak System. Please refer to Operator’s Manual for a list of additional Precautions.

 

 

CAUTION

U.S. Federal law restricts this device to sale, distribution, and use by or on the order of a physician or other licensed eye care practitioner who has been trained in the calibration and operation of this device.

 

ADVERSE EVENTS

Please refer to Operator’s Manual for a list of Adverse Events and Complications in clinical studies for wavefront-guided PRK Patients with Myopia and Myopic Astigmatism.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
ELLIPS® FX PHACO HANDPIECE AND
WHITESTAR PHACO HANDPIECE

Rx Only

 

INDICATIONS

The WHITESTAR Phaco Handpiece is utilized during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.

 

INDICATIONS

The ELLIPS® FX Phaco Handpiece is utilized during the phacoemulsification procedure to break up (emulsify) the nucleus of the cataractous lens and remove the remaining nuclear fragments.

 

CAUTIONS

Never attempt to straighten a bent needle. This will products a broken tip when phaco power is applied. Do not clean the phaco handpiece with any type of ultrasonic cleaning device; it will damage the piezoelectric crystals. Do not use tap water for cleaning. Do not sterilize the handpiece prior to performing the cleaning procedure described in the directions for use.

 

PRECAUTIONS

Only use this ELLIPS® FX Phaco Handpiece and WHITESTAR Phaco Handpiece with the WHITESTAR SIGNATURE® phacoemulsification machine. Overall system performance may be impaired when used in combination with non-Johnson & Johnson Surgical Vision products. It is important that the electrical connector on the handpiece is completely dry prior to connecting it to the 
WHITESTAR SIGNATURE® phacoemulsification machine receptacles. Moisture will prevent the handpiece from operating properly and you may receive a handpiece error message on the panel display of the phacoemulsification machine if the connector is wet.

 

WARNINGS

Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. In addition, the function and life expectancy of the phaco handpiece may become compromised. The use of gas sterilization is not recommended. The surgical staff must monitor the balanced salt solution height and fluid level at all times. A low bottle/bag height or empty bottle/bag affects the fluid balance and the intraocular pressure (IOP) while aspirating and can result in: Inadvertent chamber shallowing or collapse, aspiration or abrasion of iris or other eye tissue, an ultrasonic wound heating commonly called wound burn (extreme case)

 

ATTENTION

Reference the Directions for Use for a complete listing of indications, warnings, and precautions.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON GV® PRO Ophthalmic Viscoelastic Device (OVD)

Rx Only

INDICATIONS

The HEALON GV® PRO OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON GV® PRO OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON GV® PRO OVD can also be used to efficiently separate and control ocular tissues. The HEALON GV® PRO OVD is not designed to have any pharmacological effect.

CONTRAINDICATIONS

There are no known contraindications to the use of the HEALON GV® PRO OVD when used as recommended.

WARNINGS

HEALON GV® PRO OVD is difficult to remove from the eye. It is a high-viscosity cohesive OVD that displays dispersive behavior during removal. This behavior during removal is different compared to the similarly named HEALON GV® OVD. Adequate removal of HEALON GV® PRO OVD may require the specific surgical removal techniques described below. Users should weigh the potential benefit/risk ratio of using this device based on their own personal skill and comfort level with the recommended surgical removal techniques.

PRECAUTIONS

As a result of non-clinical and clinical experience, during removal,
HEALON GV® PRO OVD performs similarly to HEALON5® and
HEALON5® PRO OVDs, two high-viscosity OVDs that are more difficult to remove from the eye compared to typical cohesive OVDs. Two surgical removal techniques were previously studied with the original HEALON5® OVD and were shown to be effective at removing HEALON5® OVD from the eye; The Behind the Lens or the Two-Compartment Technique (TCT) was superior to the Rock'n Roll technique with regards to IOP elevation in a clinical study. Since HEALON GV® PRO OVD performs similarly to HEALON5® OVD during OVD removal, the following two surgical techniques are recommended to remove HEALON GV® PRO OVD from the eye. The safety and effectiveness of other removal techniques have not been demonstrated in a clinical study. The following removal technique (Behind the Lens or TCT) is one option to ensure removal of the HEALON GV® PRO OVD. Use a standard I/A tip, 0.3 mm, with effectual flow of 20-25 ml/min and vacuum of 250-300 mmHg with a potential maximum setting at 500 mmHg. When using a machine with a peristaltic pump, use the upper limits of the suggested settings. When using a Venturi pump use the lower limits of the suggested settings. Bottle height should be 60-70 cm above eye level. Start the removal directly after the IOL implantation, while the anterior chamber is still filled with the HEALON GV® PRO OVD and before the IOL has been centered. Go behind the IOL optic without engaging the flow of the I/A tip (port up) and then start flow. Remove the HEALON GV® PRO OVD from the capsular bag first and ensure that the lens has adequately centered. While maintaining continuous flow remove the tip from behind the optic and place it on top of the optic. Continue the removal by circling the I/A tip at the iris plane, or on the optic surface, then make an additional sweep in the anterior chamber paying particular attention to the angles. HEALON GV® PRO OVD may also be removed by creating maximum turbulence to make the HEALON GV® PRO OVD fracture into large pieces. This can be accomplished by using the Rock’n Roll technique (described below) with standard I/A tip, 0.3 mm, with high settings, flow rates should be 25-30 ml/min and vacuum 350-500 mmHg, depending on the type of pump. If a peristaltic pump is used, the vacuum should be set towards the higher limit. If a Venturi pump is used, the vacuum should be set towards the lower limit. Bottle height should be 60-70 cm above eye level. For phacoemulsification machines that use linear foot pedal control, the suggested settings can only be achieved if the surgeon operates the phacoemulsification machine with fully depressed foot pedal. Settings will vary according to user preference for different types of programmable foot pedals. Start by circling the hand piece in the anterior segment at iris plane. Gently rest the I/A piece on the anterior surface of the optic. Press on the IOL optic on one side and rotate the I/A hand piece directing the flow into the bag. Direct the hand piece port towards the equator of the capsular bag and stay in this position for a few seconds and then repeat on the other side of the IOL optic until the
HEALON GV® PRO OVD is completely removed. Finally, sweep the anterior chamber including the angles. Note: The above phacoemulsification machine settings were used in a HEALON5® clinical study. Individual phacoemulsification system parameters vary. Although phacoemulsification machine settings may need to be altered due to differences in phacoemulsification machine technology, only the machine settings that are described above were shown to be effective at removing HEALON5® OVD in a clinical study. The safety and effectiveness of other phacoemulsification machine settings have not been demonstrated in a clinical study. A transient myopic shift may also occur if the HEALON GV® PRO OVD is not completely removed from the capsular bag behind the intraocular lens. Postoperative intraocular pressure (IOP) may be increased if the HEALON GV® PRO OVD is left in the eye. Special care should be taken to ensure complete removal of the HEALON GV® PRO OVD from the entire eye including behind the lens and the chamber angles. Continued irrigation/aspiration after displacement of the initial bolus of viscoelastic from the eye should facilitate removal of viscoelastic if remaining in the anterior segment; additional surgical maneuvers are likely needed to remove OVD that is trapped behind the lens. Due to the greater viscosity of the
HEALON GV® PRO OVD, increase in postoperative IOP may be higher than that caused by leaving the same amount of other sodium hyaluronate viscoelastic products with lower zero shear viscosity in the anterior chamber. Since rises in postoperative pressure, including cases of significant elevation and rare incidents of complications (including ischemic optic neuropathy, retinal vascular occlusion, corneal edema, increased light sensitivity/photophobia, swelling of capsular bag, unexpected post-operative refraction, pain, nausea, post-operative iris constriction and loss of vision in glaucoma patients), have been reported, the following precautions are strongly recommended. Postoperative IOP may be elevated as a result of pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure. The following precautions are recommended: do not overfill the eye chambers with the HEALON GV® PRO OVD, completely remove the HEALON GV® PRO OVD by irrigation and/or aspiration at the close of the surgery and carefully monitor intraocular pressure, especially during the immediate postoperative period. Treat with appropriate intraocular pressure lowering therapy, if required. Prophylactic pressure lowering treatment should always be considered. The potential for early and short-term post-operative IOP spikes exists with cohesive OVDs, that require time and care to remove from the eye. Therefore, it is recommended that HEALON GV® PRO OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Overfilling the anterior segment of the eye with the HEALON GV® PRO OVD may cause increased intraocular pressure, glaucoma, or other ocular damage. Using higher molecular weight, high concentration viscoelastics, such as HEALON GV® PRO OVD, may impede aspiration and/or potentially lead to blockage of aspiration flow through phaco tubing, especially when reuse of aspiration tubing, use of multiple vials of viscoelastics and/or lens fragments are combined. Carefully examine the
HEALON GV® PRO OVD as it is injected and during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured. Product and cannula are for single use only. Re-use may cause eye inflammation.

ADVERSE REACTIONS

Increased intraocular pressure has been reported after use of the
HEALON GV® PRO OVD. Increased intraocular pressure is likely to occur if the HEALON GV® PRO OVD is not removed as completely as possible. Clinical judgement concerning the use of this product should be considered in cases where thorough removal may not be possible. Any increase in postoperative intraocular pressure should be managed to reduce the likelihood of occurrence of related postoperative complications such as optic neuropathy, pupillary atonia and dilation, and iris atrophy. Rarely, postoperative inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal decompensation, have been reported. A transient rise of intraocular pressure postoperatively has been reported in some cases. In posterior segment surgery intraocular pressure rises have been reported in some patients, especially in aphakic diabetics, after injection of large amounts of the
HEALON® PRO OVD.

SERIOUS ADVERSE EVENTS

The most frequently reported serious adverse events that occurred during the clinical trial of the HEALON5® PRO were intraocular pressure (IOP) spikes ≥30 mmHg (18 eyes, 8.5%) and surgical reintervention (AC Taps to treat the elevated IOP, 7 eyes, 3.3%). In the HEALON Endocoat® study, ninety- two percent of the adverse events were IOP >30 mmHg; incidence of IOP >30 mmHg occurred at a rate of 10.5%.

ATTENTION

Reference the Directions for Use for a complete listing of Important Indications and Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON5® PRO Ophthalmic Viscoelastic Device (OVD)

Rx Only

INDICATIONS

The HEALON5® PRO OVD is intended for use in anterior segment ophthalmic surgical procedures of the human eye. The HEALON5® PRO OVD is designed to create and maintain a deep anterior chamber which facilitates manipulation inside the eye with reduced trauma to the corneal endothelium and other ocular tissues. The HEALON5® PRO OVD can also be used to efficiently separate and control ocular tissues. The HEALON5® PRO OVD is not designed to have any pharmacological effect.

CONTRAINDICATIONS

There are no known contraindications to the use of the HEALON5® PRO OVD when used as recommended.

PRECAUTIONS

Precautions normally considered during ophthalmic surgical procedures should be taken. Special care should be taken to ensure complete removal of the HEALON5® PRO OVD from the entire eye including behind the lens and the chamber angles. Complete removal of the HEALON5® PRO OVD is important to avoid intraocular pressure peaks postoperatively. Due to the greater viscosity and higher concentration of sodium hyaluronate in the HEALON5® PRO OVD, the rise in the postoperative intraocular pressure may be higher with the HEALON5® PRO OVD than if the same volume of other sodium hyaluronate viscoelastic products, with lower zero shear viscosity, is left in the anterior segment of the eye. Before initiating phacoemulsification, use irrigation/aspiration to create a fluid filled space above the lens. This reduces the risk of initial visco-occlusion of the phaco tip or the irrigation line which could cause phaco tip heating. Pre-existing glaucoma, other causes of compromised outflow, higher preoperative intraocular pressure and complications in surgical procedures may also lead to increased intraocular pressure; consequently, extra care should be taken in patients with these conditions. Prophylactic pressure lowering treatment should always be considered and especially in cases where the HEALON5® PRO OVD has to be left in the eye for clinical reasons.

The HEALON5® PRO OVD is a highly purified fraction extracted from avian tissues or from fermented bacteria which may contain minute amounts of protein. Express a small amount of the HEALON5® PRO OVD from the syringe prior to use and carefully examine it during use to avoid injecting minute rubber particles which may be released when the syringe diaphragm is punctured. Sodium hyaluronate solution may appear cloudy or form precipitates when it is injected. In-vitro studies have shown incompatibility, resulting in opalescence, between sodium hyaluronate and solutions containing cationic components, e.g., detergents and benzalkonium chloride. Reprocessed cannulas should not be used. Do not use if the blister package has been damaged. Do not resterilize. The potential for early and short-term post-operative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON5® PRO OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early post-operative IOP spikes. Product and cannula are for single use only. Re-use may cause eye inflammation.

ADVERSE EVENTS

Increased intraocular pressure has been reported after use of sodium hyaluronate solutions. Increased intraocular pressure is likely to occur if the
HEALON5® PRO OVD is not removed as completely as possible. Clinical judgment concerning the use of this product should be considered in cases where thorough removal may not be possible. The precautions noted above should be taken to manage any increased postoperative intraocular pressure and to reduce the likelihood of occurrence of related postoperative complications such as optic neuropathy, pupillary atonia and dilation, and iris atrophy. Rarely, postoperative inflammatory reactions (iritis, hypopyon, endophthalmitis) following the use of sodium hyaluronate, as well as incidents of corneal edema and corneal edema and corneal decompensation, have been reported. Their relationship to sodium hyaluronate has not been established.

SERIOUS ADVERSE EVENTS

HEALON5® PRO data is applicable to HEALON® PRO OVD. The most frequently reported serious adverse events that occurred during the clinical trial of the HEALON5® PRO were intraocular pressure (IOP) spikes ≥30 mmHg (18 eyes, 8.5%) and surgical reintervention (AC Taps to treat the elevated IOP, 7 eyes, 3.3%). One eye was reported with keratitis secondary to Sjogren’s, one eye was reported with Mild TASS, and one eye was reported with proliferative diabetic retinopathy. No other serious adverse events occurred during the trial.

ATTENTION

Reference the Directions for Use for a complete listing of Important Indications and Safety Information.

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE
HEALON ENDOCOAT® OVD

Rx Only

CAUTION

Federal law restricts this device to sale, distribution and use by or on the order of a physician.

INDICATIONS

HEALON EndoCoat® OVD is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including:

  • Cataract surgery with an intraocular lens.
  • Cataract surgery without an intraocular lens.
  • Secondary intraocular lens implantation.

HEALON EndoCoat® OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation.

CONTRADICTIONS

At present, there are no contraindications to the use of HEALON EndoCoat® OVD when used as recommended.

WARNINGS

The HEALON EndoCoat® OVD Delivery system is not designed or intended to be attached to instruments other than the one provided with the product. Failure to follow the "Directions for Use" may result in cannula detachment. Mixing of quaternary ammonium salts, such as benzalkonium chloride, with sodium hyaluronate results in the formation of a precipitate. The eye should not be irrigated with any solution containing benzalkonium chloride if
HEALON EndoCoat® OVD is to be used during surgery.

PRECAUTIONS

CAUTIONS

Injection of viscoelastics creates pressure in the syringe. To prevent expulsion of the cannula into the eye, ensure that the cannula is securely attached to the fitting on the syringe. Use of the cannula guard is recommended. The cannula should be fastened securely to the syringe; however, over tightening may cause the hub to weaken and possibly detach from the syringe. Extrusion of a test droplet is recommended prior to entering the eye, and excessive force on the plunger should be avoided. Do not reuse the cannula. This could release particulate matter. Product and cannula are for single use only. Re-use may cause eye inflammation. The potential for early and short-term postoperative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON EndoCoat® OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Observe the usual precautions taken during anterior segment surgery. Pre-existing glaucoma, the surgery itself, or retained viscoelastic (particularly in patients with compromised trabecular meshwork) can cause increased intraocular pressure after the procedure. The following precautions should be carefully considered:

  • The intraocular pressure of postoperative patients should be carefully monitored, particularly in the early post operative period.
  • Do not use excessive amounts of HEALON EndoCoat® OVD.
  • Remove HEALON EndoCoat® OVD completely from the anterior chamber at the end of the procedure.
  • Corrective therapy should be initiated if the postoperative intraocular pressure rises above safe levels.
  • For intraocular use only.
  • Store at 2-25°C (36-77°F).
  • Protect from freezing.
  • Protect from light.
  • Use only if solution is clear.
  • Avoid trapping air bubbles.
  • Contents are sterile when the package is sealed and undamaged.
  • Use aseptic technique.
  • Do not use in cases of known hypersensitivity to any of the ingredients of this product.
  • See product expiration date.

HEALON EndoCoat® OVD does not require refrigeration. If refrigerated,
HEALON EndoCoat® OVD should be allowed to attain room temperature prior to use. There have been isolated reports of diffuse particulates or haziness appearing after injection of viscoelastics into the eye. While such reports are infrequent and seldom associated with any effects on ocular tissue, the physician should be aware of this occurrence. If observed, the viscoelastic should be removed by irrigation and/or aspiration. HEALON EndoCoat® OVD is derived from microbial fermentation by a purified proprietary process. Although precautions have been taken to make this device protein-free, it may contain trace amounts of protein. The physician should be aware of the potential allergic risks such as postoperative inflammation that can occur with injection of biological materials.

ADVERSE REACTIONS

Because sodium hyaluronate is a polysaccharide present in many tissues of the body, it is extremely well tolerated in human eyes. There have been reports of transient postoperative ocular inflammation (oral and/or topical steroid treatments were administered) and transient postoperative increases in intraocular pressure during clinical trials with viscoelastics. In addition to the above, the following adverse reactions have been reported following the use of sodium hyaluronate in intraocular surgery: inflammation, corneal edema, increased intraocular pressure, secondary glaucoma and corneal decompensation. All of the adverse reactions described above are potential adverse reactions for HEALON EndoCoat® OVD.

ADVERSE EVENTS

During the clinical trial, elevated intraocular pressure ≥ 30 mmHg occurated at a rate of 10.5% in the HEALON EndoCoat® OVD group, and treatment of cystoid macular edema (CME) occurred at a rate of 0.5%.

INDICATIONS AND IMPORTANT SAFETY INFORMATION for HEALON® PRO Ophthalmic Viscoelastic Device (OVD)

Rx Only

INDICATIONS

The HEALON® PRO OVD is indicated for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery.

In surgical procedures in the anterior segment of the eye, instillation of the HEALON® PRO OVD serves to maintain a deep anterior chamber during surgery, allowing for efficient manipulation with less trauma to the corneal endothelium and other surrounding tissues. Furthermore, its viscoelasticity helps to push back the vitreous face and prevent formation of a postoperative flat chamber.

In posterior segment surgery the HEALON® PRO OVD serves as a surgical aid to gently separate, maneuver and hold tissues. The HEALON® PRO OVD creates a clear field of vision thereby facilitating intra- and post-operative inspection of the retina and photocoagulation.

CONTRAINDICATIONS

At present there are no known contraindications to the use of the  HEALON® PRO OVD when used as recommended.

PRECAUTIONS

Those normally associated with the surgical procedure being performed. Overfilling the anterior or posterior segment of the eye with the HEALON® PRO OVD may cause increased intraocular pressure, glaucoma, or other ocular damage. Postoperative intraocular pressure may also be elevated as a result of preexisting glaucoma, compromised outflow and by operative procedures and sequelae thereto, including enzymatic zonulysis, absence of an iridectomy, trauma to filtration structures, and by blood and lenticular remnants in the anterior chamber. Since the exact role of these factors is difficult to predict in any individual case, the following precautions are recommended:

  • Don’t overfill the eye chambers with the HEALON® PRO OVD (except in glaucoma surgery - See Applications section in Directions for Use.
  • In posterior segment procedures in aphakic diabetic patients special care should be exercised to avoid using large amounts of the HEALON® PRO OVD.
  • Remove some of the HEALON® PRO OVD by irrigation and/or aspiration at the close of surgery (except in glaucoma surgery - See Applications section.
  • Carefully monitor the intraocular pressure, especially during the immediate postoperative period. If significant rises are observed, treat with appropriate therapy.

Care should be taken to avoid trapping air bubbles behind the HEALON® PRO OVD. Because of reports of an occasional release of minute rubber particles, presumably formed when the diaphragm is punctured, the physician should be aware of this potential problem. Express a small amount of the HEALON® PRO OVD from the syringe prior to use, and carefully examine the remainder as it is injected. Reprocessed cannulas should not be used. Sporadic reports have been received indicating that the HEALON® OVD may become ”cloudy” or form a slight precipitate following instillation into the eye. The clinical significance of these reports, if any, is not known since the majority received to date does not indicate any harmful effects on ocular tissues. The physician should be aware of this phenomenon and, should it be observed, remove the cloudy or precipitated material by irrigation and/or aspiration. In vitro laboratory studies suggest that this phenomenon may be related to interactions with certain concomitantly administered ophthalmic medications. Use only if solution is clear. Product and cannula are for single use only. Re-use may cause eye inflammation. The potential for early and short-term post-operative intraocular pressure (IOP) spikes exists with dispersive OVDs, which potentially require more time and care to remove from the eye. Therefore, it is recommended that HEALON® PRO OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation solution to reduce the risk of early postoperative IOP spikes. Do not use if the blister pack has been damaged.

ADVERSE REACTIONS

The HEALON® PRO OVD is extremely well tolerated after injection into human eyes. A transient rise of intraocular pressure postoperatively has been reported in some cases. In posterior segment surgery intraocular pressure rises have been reported in some patients, especially in aphakic diabetics, after injection of large amounts of the HEALON® PRO OVD. Rarely, postoperative inflammatory reactions (iritis, hypopyon) as well as incidents of corneal edema and corneal decompensation have been reported. Their relationship to the HEALON® PRO OVD has not been established.

SERIOUS ADVERSE EVENTS

HEALON5® PRO OVD data is applicable to HEALON® PRO OVD. The most frequently reported serious adverse events that occurred during the clinical trial of the HEALON5® PRO were intraocular pressure (IOP) spikes ≥30 mmHg (18 eyes, 8.5%) and surgical reintervention (AC Taps to treat the elevated IOP, 7 eyes, 3.3%).  One eye was reported with keratitis secondary to Sjogren’s, one eye was reported with Mild TASS, and one eye was reported with proliferative diabetic retinopathy.  No other serious adverse events occurred during the trial.

ATTENTION

Reference the Directions for Use for a complete listing of Important Indications and Safety Information.

PP2021CT5184