EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
Issue link: https://digital.eyeworld.org/i/1186984
enVistatoric.com • 800.338.2020 INDICATIONS: Indicated for primary implantation in the capsular bag of the eye in adult patients for the visual correction of aphakia in adult patients and corneal astigmatism following removal of a cataractous lens for improved uncorrected distance vision. WARNINGS: Physicians considering lens implantation in patients with pre-existing conditions, or in the event of surgical difficulties at the time of cataract extraction, should weight the potential risk/benefit ratio. Rotation of enVista ® toric IOL away from the intended axis can reduce the astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. PRECAUTIONS: Do not attempt to resterilize this lens. Do not use if the packaging is damaged or if there are signs of leakage. Do not store lenses at temperatures over 43°C (110°F) or lower than 0°C (32°F). Do not reuse the lens. Safety and effectiveness of the enVista toric IOL have not been substantiated in patients with conditions and intraoperative complications as outlined in the enVista toric IOL Directions for Use. ADVERSE EVENTS: As with any surgical procedure, risk is involved. Potential adverse events 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). Secondary surgical interventions include, but are not limited to: lens repositioning, lens replacement, vitreous aspiration or iridectomy for pupillary block, wound leak repair, and retinal detachment repair. CAUTION: Federal law restricts this device to sale by or on the order of a physician. ATTENTION: This is not all you need to know. Please refer to the Directions For Use labeling for a complete listing of indications, full risk and safety information, clinical study information, etc. Reference: 1. enVista toric Directions for Use. ®/ ™ are trademarks of Bausch & Lomb Incorporated or its affiliates. © 2019 Bausch & Lomb Incorporated or its affiliates. EVT.0032.USA.19 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.