Eyeworld

TECNIS Eyhance ™ IOL rede nes and surpasses what's been done with standard IOLs. *1,2 Also available in TECNIS ™ Toric II SEE THE DATA DISTANCE PLUS * WITHOUT COMPROMISE ** 1-3 *The TECNIS Eyhance ™ IOLs are designed to slightly extend the depth of focus compared to the TECNIS ™ 1-Piece IOL, Model ZCB00 as measured in bench testing. **Best contrast and low light performance day and night vs Acrysof ® IQ (SN60WF), Clareon ® (CNA0T0), Vivinex ™ (XY1), enVista ® (MX60E) and Acrysof ® (SA60AT). REFERENCES: 1. REF2022CT4107 Z311524E_A TECNIS Eyhance ™ IOL with TECNIS SIMPLICITY ™ Delivery System US DFU. 2. REF2021CT4007 Z311525E_A TECNIS Eyhance ™ Toric II IOL with TECNIS SIMPLICITY ™ Delivery System DFU. 3. DOF2021CT4002 - RUSH: TECNIS Eyhance ™ IOL Monofocal Competitors MTF – US. INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance ™ and TECNIS Eyhance ™ Toric II IOLs with TECNIS SIMPLICITY ™ Delivery System Rx Only INDICATIONS FOR USE: The TECNIS SIMPLICITY ™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance ™ IOL for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag. The TECNIS SIMPLICITY ™ Delivery System is used to fold and assist in inserting the TECNIS Eyhance ™ Toric II IOLs for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsifi cation and who desire reduction in residual refractive cylinder. The lens is intended to be placed in the capsular bag. WARNINGS: Physicians considering lens implantation should weigh the potential risk/benefi t ratio for any conditions described in the Directions for Use that could increase complications or impact patient outcomes. The lens should be placed entirely in the capsular bag. Do not place the lens in the ciliary sulcus. Rotation of the TECNIS Eyhance ™ 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. Do not attempt to disassemble, modify or alter the delivery system or any of its components, as this can signifi cantly 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: The safety and effectiveness of the TECNIS Eyhance ™ IOL has not been substantiated in clinical trials and the effects of the optical design on quality of vision, contrast sensitivity, and subjective visual disturbances (glare, halo, etc.) have not been evaluated clinically. 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. ADVERSE EVENTS: The most frequently reported cumulative adverse event that occurred during the SENSAR ® 1-Piece IOL clinical trial was cystoid macular edema which occurred at a rate of 3.3%. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. Third party trademarks are the property of their respective owners. © Johnson & Johnson Surgical Vision, Inc. 2024 2024PP04732 v2

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