TECNIS Symfony^™ OptiBlue^™ IOL

1. Data on file. DOF2020OTH4004, Johnson & Johnson Vision, Inc. Santa Ana, Calif. Alcon AcrySof IQ Vivity^® IQ DLU.
2. Johnson & Johnson Vision (2020) Data on File. DOF2020OTH4010.
3. Johnson & Johnson Vision (2020) Data on File. DOF2020OTH4011.
4. Son HS, Kim SH,Auffarth GU et al. (2019)Prospective comparative study of tolerance to refractive errors after implantation of extended depth of focus and monofocal intraocular lenses with identical aspheric platform in Korean population. BMC Ophthalmol 19: 187.
5. Nixon DR. Pattern of posterior capsule opacification models 2 years postoperatively with 2 single-piece acrylic intraocular lenses. 2010.
6. Kugelberg M, et al. Posterior capsule opacification after implantation of a hydrophilic or a hydrophobic acrylic intraocular lens: one-year follow up. JCRS 2006;32 (10):1627–1631.
7. REF2014OTH0002 150 Data on File – Sensar Not associated with Glistenings – Literature Analysis

INDICATION AND IMPORTANT SAFETY INFORMATION for the TECNIS Symfony^™ OptiBlue^™ Extended Range of Vision IOL with TECNIS SIMPLICITY^™ Delivery System and TECNIS Symfony^™ Toric II OptiBlue^™ Extended Range of Vision IOL with TECNIS SIMPLICITY^™ Delivery System

Rx Only

INDICATIONS:

The TECNIS SIMPLICITY^™ Delivery System is used to fold and assist in inserting the TECNIS Symfony^™ OptiBlue^™ Extended Range of Vision 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 lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The lens is intended for capsular bag placement only.

The TECNIS SIMPLICITY ^™ Delivery System is used to fold and assist in inserting the TECNIS Symfony^™ Toric II OptiBlue^™ Extended Range of Vision IOLs that 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. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only.

WARNINGS:

Physicians considering lens implantation under any of the following circumstances should weigh the potential risk/benefit ratio:

1. 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:

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) Children under the age of 2 years are not suitable candidates for intraocular lenses.

i) Congenital bilateral cataracts.

j) Previous history of, or a predisposition to, retinal detachment.

k) Patients with only one good eye with potentially good vision.

l) Medically uncontrollable glaucoma.

m) Corneal endothelial dystrophy.

n) Proliferative diabetic retinopathy.

2. The TECNIS Symfony^™ OptiBlue^™ IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus.

3. The TECNIS Symfony^™ OptiBlue^™ IOL may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. The physician should carefully weigh the potential risks and benefits for each patient, and should fully inform the patient of the potential for reduced contrast sensitivity before implanting the lens in patients. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease which may cause present or future reduction in acuity or contrast sensitivity, and patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions.

4. Some visual effects associated with the TECNIS Symfony^™ OptiBlue^™ IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL.

5. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for implantation with the TECNIS Symfony^™ OptiBlue^™ IOL, Model DXR00V, and the TECNIS Symfony^™ Toric II OptiBlue^™ IOLs, Models DXW150, DXW225, DXW300, and DXW375, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism.

6. The effectiveness of TECNIS Symfony^™ Toric II OptiBlue^™ IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism < 1.0 diopter has not been demonstrated.

7. Rotation of TECNIS Symfony^™ Toric II OptiBlue^™ IOLs away from their intended axis can reduce their 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.

8. Johnson & Johnson Surgical Vision, Inc. IOLs are single-use devices only. Do not reuse this IOL.

9. 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.

10. Do not use if the cartridge of the delivery system is cracked or split prior to implantation.

11. Do not implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system.

12. Do not stop, reverse or advance the plunger too slowly (for example more than 1 second) during initial IOL advancement. Doing so may result in improper folding of the lens.

13. Do not advance the IOL from the Holding Position (Figure 11) prior to fully hydrating the system. A minimum of 1 minute at the Holding Position is required to fully hydrate the system to prevent sticking and a potential scratch or crack to the IOL.

14. Do not advance the IOL from the Holding Position until ready for implantation. Interruptions during delivery may result in the IOL being scratched or cracked or stuck in the cartridge. Discard the device if the IOL has been advanced past the Holding Position but not delivered within 60 seconds.

15. 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.

16. 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.

17. 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.

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 or viscoelastics is required when using the delivery system. For optimal performance when using OVD, use the HEALON^™ family of viscoelastics. The use of balanced salt solution 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. 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.

10. When performing refraction in patients implanted with the TECNIS Symfony^™ OptiBlue^™ IOL, 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 recommended.

11. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the TECNIS Symfony^™ OptiBlue^™ IOL optical design.

12. 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.

13. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved.

14. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions.

15. Do not leave the lens in a folded position more than 10 minutes.

16. 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.

17. The safety and effectiveness of TECNIS Symfony^™ OptiBlue^™ IOLs have not been substantiated in patients with preexisting ocular conditions and intraoperative complications (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

18. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case. Residual viscoelastic and/or overinflation of the capsular bag may allow the lens to rotate, causing misalignment of the TECNIS Symfony^™ Toric II OptiBlue^™ IOL with the intended axis of placement.

19. 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 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.

20. The use of methods other than the TECNIS^™ Toric Calculator to select cylinder power and appropriate axis of implantation were not assessed in the parent 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 Calculator (www.TecnisToricCalc.com), are recommended to achieve optimal visual outcomes for the TECNIS Symfony^™ Toric II IOL.

21. All preoperative surgical parameters are important when choosing a TECNIS Symfony^™ Toric II OptiBlue^™ IOL for implantation, including preoperative keratometric cylinder (magnitude and axis), incision location, surgeons 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.

22. All corneal incisions were placed temporally in the parent 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 in the clinical study for the parent TECNIS^™ Toric IOL. Note that the TECNIS^™ Toric Calculator incorporates the surgeon’s estimated SIA and incision location when providing IOL options.

23. Potential adverse effects (e.g., complications) associated with the use of the device include the following:

• Infection (endophthalmitis)

• Hypopyon

• IOL dislocation

• Cystoid macular edema

• Corneal edema

• Pupillary block

• Iritis

• Retinal detachment/tear

• Raised IOP requiring treatment

• Visual symptoms requiring lens removal

• Tilt and decentration requiring repositioning

• Residual refractive error resulting in secondary intervention.

Secondary surgical interventions include, but are not limited to:

• Lens repositioning (due to decentration, rotation, subluxation, etc.)

• Lens replacement

• Vitreous aspirations or iridectomy for pupillary block

• Wound leak repair

• Retinal detachment repair

• Corneal transplant

• Lens replacement due to refractive error

• Unacceptable optical/visual symptoms

• Severe inflammation.

SERIOUS ADVERSE EVENTS

The most frequently reported serious adverse events during the clinical trial of the TECNIS Symfony^™ 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. Overall, 2.7% (4/148) of TECNIS Symfony^™ subjects experienced serious adverse events during the study and 0% (0/148) experienced device-related or unanticipated events.

ATTENTION

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