AMO and the AMO logo are registered trademarks and The Future In Sight, Verisyse and TECNIS are trademarks of Advanced Medical Optics, Inc. ©2004 ADVANCED MEDICAL OPTICS, INC. Santa Ana, CA 92799 www.amo-inc.com
Intended Use Statement: Verisyse™ Phakic Intraocular Lenses are intended for the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2.5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3.2mm, and for patients with documented stability of manifest refraction for the prior six months as demonstrated by a spherical equivalent change of less than or equal to 0.50 diopter. Rx Only. Precautions: Do not resterilize this lens by any method; do not store the lens at temperatures over 45°C (113°F). Warnings: Surgeons should consider the risk/benefit ratio for adults with preoperative ocular pathology, including but not limited to inflammation, distorted eye and microbial infection. Adverse Events: Adverse events that have been documented as having occurred following lens implantation include, but are not limited to, hyphema, retinal detachment and lens dislocation. For a complete listing of precautions, warnings and adverse events, refer to the package insert. |