AcrySof® IQ ReSTOR® Family of Multifocal IOLs 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 ReSTOR® Posterior Chamber Intraocular Multifocal IOLs include AcrySof® IQ ReSTOR® and AcrySof® ReSTOR® Toric and are intended for primary implantation 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. In addition, the AcrySof IQ ReSTOR Toric IOL is intended to correct pre-existing astigmatism. The lenses are intended to be placed in the capsular bag.
WARNINGS/PRECAUTIONS: 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 labeling for each IOL. 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.
The ReSTOR Toric IOL should not be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation.
Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. A reduction in contrast sensitivity may occur in low light conditions. Visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary; some patients may need glasses when reading small print or looking at small objects.
Posterior capsule opacification (PCO), when present, may develop earlier into clinically significant PCO with multifocal IOLs. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon informing them of possible risks and benefits associated with the AcrySof® IQ ReSTOR® IOLs.
Do not resterilize; 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 each IOL for a complete listing of indications, warnings and precautions.