Eyeworld

INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR TECNIS ODYSSEY™ IOL WITH TECNIS SIMPLICITY™ DELIVERY SYSTEM, MODEL DRN00V. Rx Only. INDICATIONS: The TECNIS SIMPLICITY™ Delivery System is used to fold and assist in inserting the TECNIS Odyssey™ 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. Compared to an aspheric monofocal lens, the TECNIS Odyssey™ 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 may not fully benefit in terms of reducing spectacle wear. 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 Odyssey™ IOLs should not be placed in the ciliary sulcus. Patients with a predicted postoperative astigmatism greater than 1.0 D may not be suitable candidates for implantation with the TECNIS Odyssey™ 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. Third party trademarks are the property of their respective owners. © Johnson & Johnson and its affiliates 2024 I 2024PP11319 *Based on bench testing **According to ISO 11979-7:2024, based on the clinical study of the parent IOL. † Compared to PanOptix ® based on objective pre-clinical halo performance ¶ Compared to PanOptix ® based on bench testing ‡ Compared to leading competitor full range of vision IOLs based on bench testing § 20/25 or better based on bench testing REFERENCES: 1. Data on File. 2024DOF4002 2. Data on File. DOF2023CT4052 3. Data on File. 2024DOF4005 4. Data on File. DOF2023CT4023 5. Data on File. DOF2023CT4007 6. Data on File. DOF2019OTH4002 LEARN MORE Precise vision. Every distance. Any lighting . • High tolerance to refractive error 2 • Better dysphotopsia profile †3 • Unmatched range of vision ¶4 • Best-in-class contrast ‡5-6 Elevate your practice with TECNIS Odyssey™, the high-quality*, continuous full visual range IOL 1§ **. Discover its optimized, freeform surface designed to deliver:

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