EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.
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TECNIS ® Toric IOL Secure rotational stability. Deliver precise outcomes. The TECNIS ® Toric IOL exceeds the ANSI (American National Standards Institute) criteria for toric lens rotational stability* 1 – a critical factor in postoperative visual outcomes. 2 The IDE study showed: • 94% of eyes had a change of axis ≤5° between baseline and six months 1 • Average rotation during the same time period was 2.74° 1 *ANSI Z80.30-2010 requires that >90% of eyes experience a change in axis of ≤5° between two consecutive visits approximately three months apart. 1. TECNIS Toric 1-Piece IOL [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc. 2. Novis C. Astigmatism and toric intraocular lenses. Curr Opin Ophthalmol. 2000; 11:47-50. TECNIS is a trademark owned by or licensed to Abbott Laboratories, its subsidiaries, or affiliates. ©2014 Abbott Medical Optics Inc. www.AbbottMedicalOptics.com 2013.01.31-CT6316 Indications: The TECNIS ® Toric 1-Piece posterior chamber lenses are 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. Warnings: Physicians considering lens implantation should weigh the potential risk/benefit ratio for any circumstances described in the TECNIS ® Toric 1-Piece IOL Directions for Use that could increase complications or impact patient outcomes. The clinical study did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter. The TECNIS ® Toric 1-Piece IOL should not be placed in the ciliary sulcus. Rotation of the TECNIS ® Toric 1-Piece IOL away from its intended axis can reduce its astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. Precautions: Accurate keratometry and biometry in addition to the use of the TECNIS Toric Calculator (www.TECNISToricCalc.com) are recommended to achieve optimal visual outcomes. The safety and effectiveness of the toric intraocular lens have not been substantiated in patients with certain preexisting ocular conditions and intraoperative complications. Refer to the TECNIS ® Toric 1-Piece IOL Directions for Use for a complete description of the preexisting conditions and intraoperative complications. All preoperative surgical parameters are important when choosing a toric lens for implantation. Variability in any of the preoperative measurements can influence patient outcomes. All corneal incisions were placed temporally in the clinical study. Do not reuse, resterilize, or autoclave. Adverse Events: The most frequently reported adverse event that occurred with the TECNIS ® Toric 1-Piece IOL was surgical reintervention, which occurred at a rate of 3.4% (lens repositioning procedures and retinal repair procedures). Other reported events included macular edema, which occurred at a rate of 2.9% and retinal detachment which, occurred at a rate of 0.6%. 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, Warnings and Precautions. Experience the proven performance of the TECNIS ® Toric IOL today. Visit www.TECNISToricIOL.com or call 1-877-AMO-4-LIFE. The newest addition to the TECNIS ® family of IOLs. For your peace of mind.