Eyeworld

Bringing astigmatism AND presbyopia into focus. INDICATIONS FOR USE: The TRULIGN ® toric posterior chamber intraocular lens (IOL) is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision. WARNINGS: Careful preoperative evaluation and sound clinical judgement should be used by the surgeon to decide the risk / benefit ratio before implanting a lens in a patient. Rotation of toric lenses away from their intended axis can reduce their effectiveness, and misalignment can increase postoperative refractive cylinder. The TRULIGN ® Toric IOL should only be repositioned when the refractive needs of the patient outweigh the potential risks inherent in any surgical reintervention into the eye. Unlike most other IOLs, the TRULIGN ® Toric IOL optic has hinges connecting it to the haptic; please see adverse events section below for more information. PRECAUTIONS: The safety and effectiveness of the TRULIGN ® Toric intraocular lenses have not been substantiated in patients with preexisting ocular conditions and intraoperative complications. Long-term stability in the human eye has not been established; therefore postoperative monitoring after implant should be performed on a regular basis. Lens rotation less than 5° may not warrant reorientation. Do not resterilize this intraocular lens by any method. Do not store lenses at temperatures over 45°C (113°F). 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 with conditions as outlined in the TRULIGN ® Toric IOL directions for use. ADVERSE EVENTS: The incidence of adverse events experienced during the clinical trial was comparable to or lower than the incidence reported in the historic control ("FDA grid") population. As with any surgical procedure, risk is involved. Vaulting is a post-operative adverse event where the TRULIGN ® Toric IOL optic hinges move into and remain in a displaced configuration. If vaulting occurs, please see Directions for Use for a detailed listing of symptoms, information regarding diagnosis, potential causes, and sequelae. Physicians should consider the characteristics of each individual vaulting case prior to determining the appropriate treatment. Data on long-term follow-up after treatment of vaulting is not available. ATTENTION: Refer to the Directions for Use labeling for a complete listing of indications, warnings and precautions, clinical trial information, etc. CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician. 1. TRULIGN Toric IOL Directions for Use. 2. Data on file, Bausch & Lomb Incorporated. Study 650. 3. AcrySof IQ Toric Directions for Use. 4. Tecnis Toric Directions for Use. ® / ™ are trademarks of Bausch & Lomb Incorporated or its affiliates. All other brand/product names are trademarks of their respective owners. ©2017 Bausch & Lomb Incorporated. CRT.0027.USA.17 TRULIGN ® Toric IOL offers the critical advantages your patients need: Full range of vision 1 | Excellent stability 2-4 | Minimized dysphotopsias 1 FROM HERE ON OUT, IT'S TRULIGN. TRULIGN.COM

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