Physicians considering use of the TECNIS® Toric II IOLs should refer to the Directions for Use labeling for a complete list of indications and safety information.
The TECNIS® Toric II 1-Piece posterior chamber lens is indicated for the visual correction of aphakia and pre-existing corneal astigmatism of one diopter or greater in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire improved uncorrected distance vision, reduction in residual refractive cylinder, and increased spectacle independence for distance vision. The device is intended to be placed in the capsular bag.
IMPORTANT SAFETY INFORMATION: The most frequently reported cumulative adverse event that occurred during the TECNIS® Toric 1-Piece IOL clinical trial was surgical re-intervention which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Rotation of these IOLs away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. Variability in any of the preoperative measurements can influence patient outcomes. Physicians should weigh the potential risk/benefit ratio for circumstances described in the Directions for Use that could increase complications or impact patient outcomes. Federal law restricts this device to sale, distribution and use by or on the order of a physician.