Eyeworld

©Johnson & Johnson and its affiliates 2025. 2025PP17385 v2 References: 1. TECNIS PureSee™ IOL, Model DEN00V, US DFU Z312075E rev B INDICATIONS and IMPORTANT SAFETY INFORMATION for TECNIS PureSee™ IOL and TECNIS PureSee™ 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 PureSee™ 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 TECNIS PureSee™ IOL provides improved intermediate 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 PureSee™ Toric II IOLs, which 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. The lenses mitigate the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the TECNIS PureSee™ Toric II IOLs provide improved intermediate visual acuity, while maintaining comparable distance visual acuity. The lenses are intended for capsular bag placement only. WARNINGS: Physicians should weigh the potential benefit/risk ratio of IOL implantation in patients with any of the conditions listed in the Directions for Use, as intraocular lenses may exacerbate an existing condition or may pose an unreasonable risk to the eyesight of patients. Rotation of the TECNIS PureSee™ Toric II IOLs away 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 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: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the benefit/risk ratio before implanting a lens in a patient. Potential risks for cataract surgery may include but are not limited to infection, inflammation, retinal detachment, increased eye pressure, hyphema, hypopyon, and posterior capsular opacification. Prior to surgery, the surgeon must inform prospective patients of the possible risks and benefits associated with the use of this device and provide a copy of the patient information brochure to the patient. Autorefractors may not provide optimal postoperative refraction of patients with the IOL. Manual refraction with maximum plus technique is strongly recommended. 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 41°F (5°C) or over 95°F (35°C). Do not autoclave 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. The sterility of the delivery system and/or the lens may have been compromised. The recommended temperature for implanting the lens is at least 63°F (17°C). Do not advance the lens unless ready for lens implantation. Do not leave the lens in a folded position more than 10 minutes. The use of balanced salt solution or ophthalmic viscosurgical devices (OVDs) is required when using the delivery system. The lens should be placed entirely in the capsular bag. The lens should not be placed in the ciliary sulcus. ATTENTION: Reference the Directions for Use for a complete listing of Indications and Important Safety Information. Pure Ease of Mind TECNIS PureSee™, the new purely refractive extended depth-of-focus IOL with monofocal-like dysphotopsia. 1 Designed for your ease of mind, 97% of patients reported no very bothersome visual disturbances. 1 Learn More

• Blank Page
• Blank Page (1)