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    TECNIS SymfonyTM Toric IOL

    TECNIS SymfonyTM 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 SymfonyTM Toric Extended Range of Vision 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 SymfonyTM IOLs

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

    Defocus Curve1

    Binocular Distance Corrected Defocus Curves at 6 Months

     

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

      Rather than splitting light into distinct focal points, the TECNIS SymfonyTM 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 Months1

      Mesopic without Glare

    Testing conducted using the TECNIS SymfonyTM IOL, and not the TECNIS SymfonyTM 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 SymfonyTM 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 astigmatism1
    • Pupil-independent performance enables optimal performance in any lighting condition1
    • Low overall spectacle wear1

    85% of patients with the TECNIS SymfonyTM Toric IOL wore glasses none or a little bit of the time.*1

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

    • Proprietary relief profile elongates focus1
    • Proprietary achromatic technology corrects chromatic aberration and enhances image contrast1

    Low incidence of visual symptoms, including halos, glare and starbursts1

    The TECNIS SymfonyTM Toric IOL delivers excellent refractive cylinder results.

    • 92% of patients achieved ≤ 0.50 D of residual refractive cylinder**1

    Unlike another leading IOL, TECNIS® IOL material is not associated with glistenings,1-5 which can inhibit your patients’ vision. Glistenings cause light scatter.2-6

    TECNIS SymfonyTM 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:7

    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 SymfonyTM IOL, not TECNIS SymfonyTM Toric IOL.

    **The study design was to evaluate the clinical outcomes of far, intermediate and near visual acuities of patients implanted with the
     TECNIS SymfonyTM 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. TECNIS SymfonyTM Extended Range of Vision IOLs DFU. Santa Ana, Calif. Johnson & Johnson Surgical Vision, Inc.;
    2. Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. J Cataract Refract Surg. 2010;36(12):2056-2060.
    3. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. J Cataract Refract Surg. 2001;27(5):728-733.
    4. 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.
    5. 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.
    6. Van der Mooren M, Franssen L, Piers P. Effects of glistenings in intraocular lenses. Biomed Opt Express. 2013;4(8):1294-304.
    7. 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 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 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 silicone 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. Never release 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. 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 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. The UNFOLDER® Silver Series Cartridge is intended for single use 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. 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® Silver Series 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 methyl cellulose viscoelastics. Follow the dwell recommendations for advanced position of the IOL.

    PRECAUTIONS

    The contents of the cartridge package 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 cartridge. For optimal performance use the JJSV HEALON® Family of Viscoelastics. Do not use balanced salt solution. 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 5°C or over 30°C.

    ATTENTION

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

     

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

    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 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. The TECNIS® 1-Piece IOL should not be placed in the ciliary sulcus.

    PRECAUTIONS

    Do not reuse, resterilize, or autoclave.

    ADVERSE EVENTS

    In 3.3% of patients, reported adverse events of cataract surgery with the TECNIS® 1-Piece IOL included macular edema.

    ATTENTION

    Reference the Directions for Use for a complete listing of 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 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.

     

    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. 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.

     

    PP2021CT4025