Review of Ophthalmology January 2012 : covtip 2
www.AcrySofReSTOR.com CAUTION : Federal (USA) law restricts this device to the sale by or on the order of a physician. INDICATIONS : The AcrySof ® IQ ReSTOR ® Posterior Cham-ber Intraocular Lens (IOL) is intended for primary implan-tation for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag. WARNING/PRECAUTION : Careful preoperative evaluation and sound clinical judgment should be used by the sur-geon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use labeling. Physicians should target emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery. Some patients may experience visual disturbances and/ or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof ® Re-STOR ® lens indicated that posterior capsule opacifica-tion (PCO), when present, developed earlier into clini-cally significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this prod-uct informing them of possible risks and benefits associ-ated with the AcrySof ® IQ ReSTOR ® IOLs. Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof ® Natural IOL and normal color vision. The effect on vision of the AcrySof ® Natural IOL in subjects with hereditary color vision defects and acquired color vision defects secondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and other retinal or optic nerve diseases) has not been studied. Do not resteril-ize; do not store over 45° C; use only sterile irrigating solutions such as BSS ® or BSS PLUS ® Sterile Intraocular Irrigating Solutions. ATTENTION : Reference the Directions for Use labeling for a complete listing of indications, warnings and precau-tions. © 2011 Novartis 8/11 RES11067JAD
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