Eyeworld

Your Patients' Lives Don't Stop at Sunset. Bring on the Night with InteliLight ™ , for the best* contrast and low-light performance across the PC IOL category.** 1-4 REFERENCES: 1. Data on file. DOF2020OTH4010 Johnson & Johnson Vision, Inc. Santa Ana, Calif. 2. Data on file. DOF2020OTH4011 Johnson & Johnson Vision, Inc. Santa Ana, Calif. 3. Data on file. DOF2015CT0020 Johnson & Johnson Vision, Inc. Santa Ana, Calif. 4. DOF2019OTH4002 – Weeber H. MTF of the TECNIS Synergy™ OptiBlue ® , and other lens models. 27 Mar 2020. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYNERGY™ IOL WITH TECNIS SIMPLICITY ® DELIVERY SYSTEM, MODEL DFR00V AND TECNIS SYNERGY™ TORIC II IOL WITH TECNIS SIMPLICITY ® DELIVERY SYSTEM, MODELS DFW150, DFW225, DFW300, DFW375 Rx Only INDICATIONS: The TECNIS Simplicity ® Delivery System is used to fold and assist in inserting the TECNIS Synergy™ 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 Synergy™ 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 Synergy™ 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. WARNINGS: 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. Patients should have well-defined visual needs and be informed of possible visual effects (such as a perception of halo, starburst 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. The physician should carefully weigh the potential risks and benefits for each patient. 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. Rotation of the TECNIS Synergy™ Toric II IOL 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. 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. 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. PRECAUTIONS: 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. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be affected by the IOL optical design. The surgeon should target emmetropia, as this lens is designed for optimum visual performance when emmetropia is achieved. The TECNIS Synergy™ IOLs should not be placed in the ciliary sulcus. 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 Synergy™ Toric II IOL. All preoperative surgical parameters are important when choosing a TECNIS Synergy™ Toric II IOL 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 Synergy™ Toric II IOLs in reducing postoperative residual astigmatism in patients with preoperative corneal astigmatism < 1.0 diopter has not been demonstrated. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Synergy™ and TECNIS Synergy™ Toric II IOLs, as they may not obtain the benefits of reduced spectacle wear or improved intermediate and near vision seen in patients with lower predicted postoperative astigmatism. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS SYMFONY™ OPTIBLUE™ AND TECNIS SYMFONY™ TORIC II OPTIBLUE™ EXTENDED RANGE OF VISION IOLS WITH TECNIS SIMIPLICITY ® 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: 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. The lens 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 for 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 TECNIS Symfony™ Toric II OptiBlue™ IOLs 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. 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 implant the lens if the rod tip does not advance the lens or if it is jammed in the delivery system. The lens and delivery system should be discarded if the lens has been folded within the cartridge for more than 10 minutes. PRECAUTIONS: 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 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 Symfony™ Toric II OptiBlue™ IOL, variability in any preoperative surgical parameters (e.g., keratometric cylinder, incision location, estimated surgically induced astigmatism, or biometry) can influence patient outcomes. Carefully remove all viscoelastic and do not over-inflate the capsular bag at the end of the case, to avoid lens rotation. This is a single use device, do not resterilize the lens or the delivery system. 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 or viscoelastics is required when using the delivery system. Do not use if the delivery system has been dropped or if any part was inadvertently struck while outside the shipping box. 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 for a complete listing of Indications and Important Safety Information. © Johnson & Johnson Surgical Vision, Inc. 2023 PP2023MLT4275 Built on the proven TECNIS ® platform. Powered by new InteliLight ™ technology. Available in two lens options † : TECNIS Synergy ™ , an EDOF and Multifocal Hybrid IOL TECNIS Symfony ™ OptiBlue ™ , a Next-Generation EDOF IOL † Also available in TECNIS ® Toric II. #PoweredByInteliLight * TECNIS Symfony ™ OptiBlue ™ vs AcrySof ® ReSTOR ® +2.5 D and AcrySof ® IQ Vivity ® . TECNIS Synergy ™ vs PanOptix ® IOL ** Considers IOLs that account for approximately 80% of the category value: AcrySof ® IQ Vivity ® . and vs. PanOptix ® IOL. Based on a comparison of DFU defocus curves and a head-to-head clinical study of TECNIS Synergy ™ vs. PanOptix ® ASCRS booth #1737

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