Eyeworld

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 e‚ ects 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-de„ ned visual needs and be informed of possible visual e‚ ects (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 e‚ ects as bothersome, which, on rare occasions, may be signi„ cant enough for the patient to request removal of the IOL. The physician should carefully weigh the potential risks and bene„ ts for each patient. Patients with a predicted postoperative residual astigmatism greater than 1.0 diopter, with or without a toric lens, may not fully bene„ t 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 signi„ cantly a‚ ect 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. Con„ rmation of refraction with maximum plus manifest refraction technique is strongly recommended. The ability to perform some eye treatments (e.g., retinal photocoagulation) may be a‚ ected 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-in' ate the capsular bag at the end of the case. Residual viscoelastic and/or over-in' ation 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 in' uence patient outcomes and the e‚ ectiveness of treating eyes with lower amounts of preoperative corneal astigmatism. The e‚ ectiveness 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 bene„ ts 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. © Johnson & Johnson Surgical Vision, Inc. 2021 PP2021CT4961 1. TECNIS Synergy TM IOL with TECNIS Simplicity ® Delivery System DFU, Z311421E 2. Data on File, Johnson & Johnson Surgical Vision, Inc. DOF2020CT4014 - Forte 1: A Comparative Clinical Evaluation of a New TECNIS ® Presbyopia Correcting Intraocular Lens Against a PanOptix ® Intraocular Lens- DEFOCUS CURVES AND VISUAL ACUITY RESULTS 3. Data on File, Johnson & Johnson Surgical Vision, Inc. DOF2019OTH4002 - Weeber H. MTF of the TECNIS Synergy TM OptiBlue ® IOL, and other lens models. 27 Mar 2019. 4. TECNIS ® Multifocal 1-Piece IOL ZKB00 and ZLB00 DfU - US - Doc. #Z311328. Rev. A, 04/2018. REF2019CT4049. 5. TECNIS Symfony™ Extended Range of Vision IOL DfU - US -Doc. #z311215. Rev. 01, 12/2017 REF2020MLT4051 6. Data on File, Johnson & Johnson Surgical Vision, Inc. DOF2020CT4015- Forte 1: A Comparative Clinical Evaluation of a New TECNIS ® Presbyopia Correcting Intraocular Lens Against a PanOptix ® Intraocular Lens- SPECTACLE WEAR AND SATISFACTION RESULTS A Breakthrough Innovation TECNIS Synergy TM IOL #GetSynergized * vs. AcrySof ® IQ PanOptix ® , TECNIS Symfony TM , TECNIS ® Multifocal. Based on comparison of DFU defocus curves and head to head clinical study vs. PanOptix. ** Continuous 20/32 or better † vs. PanOptix ® IOL ‡ Based on interim 6-months post-operative data Going beyond the limits of current trifocals. Widest* range of continuous vision** with best near* 1-5 Excellent patient outcomes so they can enjoy the moments that matter most †‡6 Superior image contrast † day and night, delivering vision that patients can trust 3

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