ACRYSOF® SINGLE-PIECE MONOFOCAL INTRAOCULAR LENSES IMPORTANT PRODUCT INFORMATION
Federal law restricts this device to sale by or on the order of a physician.
AcrySof® single-piece monofocal intraocular lenses (IOLs) include the AcrySof® IQ Aspheric Natural IOL (Model SN60WF), AcrySof® UV-Absorbing Aspheric IOL (Model SA60WF), AcrySof® Natural IOL (Model SN60AT) and AcrySof® IOL (Model SA60AT). Each IOL is indicated for visual correction of aphakia in adult patients following cataract surgery. These IOLs are intended for replacement in the capsular bag.
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting an IOL in a patient with any of the conditions described in the Directions for Use that accompany each IOL. Caution should be used prior to lens encapsulation to avoid lens decentration or dislocation. Viscoelastic should be removed from the eye at the close of surgery.
Studies have shown that color vision discrimination is not adversely affected in individuals with the AcrySof® Natural IOL (Model SN60AT) 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 resterilize. Do not store at temperatures over 45° C. Use only sterile irrigating solutions to rinse or soak IOLs.
Refer to the Directions for Use labeling for each IOL for a complete list of indications, warnings and precautions.
Click here to view the AcrySof® IQ IOL Directions For Use (DFU).