ULSTRASERT™ PRE-LOADED IOL DELIVERY SYSTEM WITH THE ACRYSOF® IQ ASPHERIC IOL IMPORTANT PRODUCT INFORMATION
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.
INDICATIONS: The AcrySof® IQ aspheric intraocular lens (“AcrySof IQ”) is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.
WARNING/PRECAUTION: Use the UltraSert™ Pre-loaded Delivery System (“UltraSert”) at temperatures between 18o C (64o F) and 23oC (73o F). Use only Alcon viscoelastic qualified for this device. Do not use the UltraSert if the nozzle appears damaged or deformed. Follow the Directions for Use for correct order and sequence of steps to avoid damage to the IOL or the UltraSert.
Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient with any of the conditions described in the Directions for Use. Caution should be used prior to lens encapsulation to avoid lens decentrations or dislocations.
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 resterilize; do not store over 45o C.
ATTENTION: Reference the Directions for Use for Model AU00T0 for a complete listing of indications, warnings and precautions.
Click here to view the AcrySof® IQ IOL with the UltraSert™ Preloaded IOL Delivery System Directions For Use (DFU).