Eyeworld

EXPERIENCE THE DIFFERENCE * 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. The new TECNIS Eyhance TM IOL — de ning the future of Monofocals. The rst monofocal lens designed to slightly extend the depth of focus 1,2,* Better image contrast in low light compared to AcrySof IQ SN60WF at 5mm 3 New TECNIS Simplicity ® system for safe and easy delivery 4 Learn more at jnjvisionpro.com/Eyhance 1. Z311524E_A TECNIS Eyhance TM IOL with TECNIS Simplicity ® Delivery System US DFU. 2. Z311525E_A TECNIS Eyhance TM Toric II IOL with TECNIS Simplicity ® Delivery System DFU. 3. Data on File, Johnson & Johnson Surgical Vision, Inc. 2021 DOF2021CT4002. 4. TECNIS ® Monofocal IOL with TECNIS Simplicity ® Delivery System (package insert, DFU DCB00 (Z311063P Rev. D). INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS Eyhance TM and TECNIS TM 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. 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 (BSS) 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. © Johnson & Johnson Surgical Vision, Inc. 2021 PP2021CT4146

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