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    TECNIS Symfony® Toric IOL

    TECNIS Symfony® Toric IOL

     
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    Instructional Guides

    Instructional Guides

    Instructional Guides

    Seamless Brilliance for Patients with Presbyopia and Astigmatism

    Designed to give your patients vivid, seamless vision, the TECNIS Symfony® Toric Extended Depth of Focus IOL addresses both presbyopia and astigmatism while delivering a full range of continuous vision.  

    Optimize your outcomes with the TECNIS® Toric Calculator.

    See the Passion in Each Patient.

    For Each Passion, There’s a TECNIS® IOL. Leading Innovation. High-Quality Vision. Exceptional Satisfaction.

    TECNIS® Symfony IOLs

    Give your patients seamless brilliance across the full range of vision. The TECNIS Symfony® Toric IOL delivers excellent uncorrected visual acuity at all distances.

    Defocus Curve1

    Binocular Distance Corrected Defocus Curves at 6 Months

     

    • The TECNIS Symfony® Toric IOL delivers the same range of continuous vision as the TECNIS Symfony® IOL.1

      Rather than splitting light into distinct focal points, the TECNIS Symfony® Toric IOL elongates focus, resulting in an increased depth of field. This empowers you to deliver a full range of continuous vision while maintaining high image contrast.

      Monocular Contrast Sensitivity at 6 Months2

      Mesopic without Glare

    Testing conducted using the TECNIS Symfony® IOL, and not the TECNIS Symfony® Toric IOL.

    Modular Transfer Function (MTF) is a measure of the amount of contrast transferred by the optics in a visual system. The higher the MTF value, the more contrast transferred to the image, resulting in higher image contrast.

    The TECNIS Symfony® Toric IOL equips you with the state-of-the-art technology you need to deliver seamless vision across the full range in any lighting condition.

    • High-quality distance vision in the presence of astigmatism2
    • Pupil-independent performance enables optimal performance in any lighting condition1
    • Low overall spectacle wear1

    85% of patients with the TECNIS Symfony® IOL wore glasses none or a little bit of the time.*2

    By combining a unique diffractive pattern with achromatic technology, the TECNIS Symfony® Toric IOL delivers outstanding visual acuity over a continuous range of distances while maintaining high contrast performance.

    • Proprietary relief profile elongates focus2
    • Proprietary achromatic technology corrects chromatic aberration and enhances image contrast2

    Degree of Difficulty With Visual Symptoms2

    Percentage of Eyes, Non-Directed Reports, 6 Months Postoperative

     

    Testing conducted using the TECNIS Symfony® IOL, and not the TECNIS Symfony® Toric IOL.

    Low incidence of visual symptoms, including halos, glare and starbursts2

    The TECNIS Symfony® Toric IOL delivers excellent refractive cylinder results.

    • 92% of patients achieved ≤ 0.50 D of residual refractive cylinder**3

    Unlike another leading IOL, TECNIS® IOL material is not associated with glistenings,2,4-8 which can inhibit your patients’ vision. Glistenings cause light scatter, which can result in a reduction in image contrast.5-9

    TECNIS Symfony® Toric IOL

    OPTIC CHARACTERISTICS

    Powers:

    +5.0 D to 34.0 D in 0.5 diopter increments

    Diameter:

    6.0 mm

    Center Thickness:

    0.7 mm (20.0 D)

    Shape:

    Biconvex, wavefront-designed anterior aspheric toric surface, posterior achromatic diffractive surface designed to reduce chromatic aberration for enhanced image contrast and echelette feature to extend the range of vision.

    Material:

    UV-blocking hydrophobic acrylic

    Refractive Index:

    1.47 at 35° C

    Edge Design:

    ProTEC frosted, continuous 360° posterior square edge

    BIOMETRY†

    CONTACT ULTRASOUND

    OPTICAL

    A-Constant:

    118.8

    119.3 

    Theoretical AC Depth:

    5.40 mm

    5.72 mm

    Surgeon Factor:10

    1.68 mm

    1.96 mm

    HAPTIC CHARACTERISTICS

    Overall Length:

    13.0 mm

    Thickness:

    0.46 mm

    Style:

    C

    Material:

    Soft, foldable, UV-blocking hydrophobic acrylic

    Design:

    TRI-FIX, haptics offset from optic, one-piece lens

    Models:

    ZXT150, ZXT225, ZXT300, ZXT375

     

    IOL INSERTION

    Recommended insertion instruments:

    FOOTNOTES

    *Testing conducted with the TECNIS Symfony® IOL, not TECNIS Symfony® Toric IOL.

    **The study design was to evaluate the clinical outcomes of far, intermediate and near visual acuities of patients implanted with the TECNIS Symfony® Toric IOL (n=39). This was a 6-month, prospective, bilateral, open label clinical investigation at two sites in New Zealand. Mean value is first eye data.

    †Value theoretically derived for a typical 22.0 D lens. Johnson & Johnson Vision recommends that surgeons personalize their A-constant based on their surgical techniques and equipment, experience with the lens model and postoperative results.

    REFERENCES

    1. Data on File. Johnson & Johnson Surgical Vision, Inc. 2016.
    2. TECNIS Symfony® Extended Range of Vision IOLs DFU. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.;
    3. Data on File. Johnson & Johnson Surgical Vision, Inc. 2016.
    4. Data on File. Johnson & Johnson Surgical Vision, Inc. 2013.
    5. Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010;36(12):2056-2060.
    6. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27(5):728-733.
    7. Colin J, et al. Incidence of glistenings with the latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. J Cataract Refract Surg. 2012;38(7):1140-1146.
    8. Gunenc U, et al. Effects on visual function of glistenings and folding marks in AcrySof® intraocular lenses. J Cataract Refract Surg. 2001;27(10):1611-1614.
    9. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013;4(8):1294-304.
    10. Calculated based on Holladay I formula: Holladay JT, Prager TC, Chandler TY, Musgrove KH, Lewis JW, Ruiz RS. A three-part system for refining intraocular lens power calculations. J Cataract Refract Surg. 1988;14(1):17-24.
     

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

    Rx Only

    INDICATIONS

    The TECNIS Symfony® Extended Range of Vision 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 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 model ZXR00 IOL is intended for capsular bag placement only. The TECNIS Symfony® Toric Extended Range of Vision IOLs, 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. 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 model series ZXT IOLs 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. 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:  patients with recurrent severe anterior or posterior segment inflammation or uveitis of unknown etiology, or any disease producing an inflammatory reaction in the eye, 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, 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, congenital bilateral cataracts, previous history of, or a predisposition to, retinal detachment, patients with only one good eye with potentially good vision, medically uncontrollable glaucoma, corneal endothelial dystrophy or proliferative diabetic retinopathy. The TECNIS Symfony® IOL should be placed entirely in the capsular bag and should not be placed in the ciliary sulcus. The TECNIS Symfony® 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. Because the TECNIS Symfony® IOL may cause a reduction in contrast sensitivity compared to a monofocal IOL, patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions. Some visual effects associated with the TECNIS Symfony® 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. Patients with a predicted postoperative astigmatism greater than 1.0 diopter may not be suitable candidates for implantation with the TECNIS Symfony® and TECNIS Symfony® Toric IOLs, models ZXR00, ZXT150, ZXT225, ZXT300, and ZXT375, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower astigmatism. The effectiveness of TECNIS Symfony® Toric IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism less than 1.0 diopter has not been demonstrated. Rotation of TECNIS Symfony® Toric 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. Johnson & Johnson Surgical Vision IOLs are single-use devices only. Do not reuse this IOL.

     

    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. When performing refraction in patients implanted with the TECNIS Symfony®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. The ability to perform some eye treatments (e.g. retinal photocoagulation) may be affected by the TECNIS Symfony® IOL optical design. 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.  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. The surgeon should target emmetropia as this lens is designed for optimum visual performance when emmetropia is achieved. Care should be taken to achieve IOL centration, as lens decentration may result in a patient experiencing visual disturbances under certain lighting conditions. When the insertion system is used improperly, TECNIS Symfony® IOLs may not be delivered properly (i.e., haptics may be broken). Please refer to the specific instructions for use provided with the insertion instrument or system. The safety and effectiveness of TECNIS Symfony® 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, or zonular damage. 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 IOL with the intended axis of placement. 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 JJSV Toric Calculator user manual for more information. 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 IOL. All preoperative surgical parameters are important when choosing a TECNIS Symfony® Toric IOL 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 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. 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, and 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 and severe inflammation. 

     

    SERIOUS ADVERSE EFFECTS

    The most frequently reported serious adverse events that occurred 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%). One eye was reported with pupillary capture and the eye that had endophthalmitis also had a small hypopyon. No other serious adverse events and no lens-related adverse events occurred during the trial.

     

    INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE 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 extra capsular cataract extraction. These devices 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 TECNIS® 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes.

    See Full Indications and Important Safety Information

    INDICATIONS AND IMPORTANT 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 JJSV 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.

    See Full Indications and Important Safety Information

    INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR THE UNFOLDER® EMERALD SERIES 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.

    See Full Indications and Important Safety Information

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

    Rx Only

     

    INDICATIONS

    The DK7786 handpiece with the One Series Ultra 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 Ultra 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.

    See Full Indications and Important Safety Information

    ATTENTION

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

    PP2018MLT4177