Eyeworld

enVistatoric.com • enVista.toriccalculator.com • 800.338.2020 INDICATIONS: The enVista one-piece hydrophobic acrylic IOL (Model MX60PL) is indicated for primary implantation in the capsular bag of the eye in adult patients for visual correction of aphakia following removal of a cataractous lens for improved uncorrected distance vision. The SimplifEYE ™ Inserter is indicated for folding and inserting of enVista IOLs (Models MX60PL and MX60PT) and IOL models approved for use with this IOL insertion device. WARNINGS: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk / benefit ratio before implanting a lens in a patient. PRECAUTIONS: Do not resterilize this intraocular lens or inserter by any method. Do no use if the packaging is damaged or if there are signs of leakage. Do not store lenses or inserter at temperatures over 43°C (109°F) or lower than 0°C (32°F). Do not reuse the lens or inserter. Safety and effectiveness of the enVista IOL have not been substantiated in patients with conditions and intraoperative complications as outlined in the enVista IOL Directions for Use. ADVERSE EVENTS: As with any surgical procedure, there is risk involved. Potential complications accompanying cataract or implant surgery may include, but are not limited to the following: corneal endothelial damage, infection (endophthalmitis), retinal detachment, vitritis, cystoid macular edema, corneal edema, pupillary block, cyclitic membrane, iris prolapse, hypopyon transient or persistent glaucoma, acute corneal decompensation, toxic anterior segment syndrome (TASS), and secondary surgical intervention. CAUTION: Federal law restricts this device to sale by or on the order of a physician. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications and important safety information. Reference: 1. enVista toric Directions for Use. ®/ ™ are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2020 Bausch & Lomb Incorporated or its affiliates. EVT.0037.USA.20 Fixated on Stability. Focused on Outcomes. 1 NO TRADEOFFS IN SIGHT.* *Both rotational stability and quality of vision/visual acuity are important for a toric IOL. E N V I S T A T O R I C I S N O W P R E L O A D E D The SimplifEYE ™ Delivery System L O A D E D W I T H P R E D I C T A B I L I T Y

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