AcrySof® IQ ReSTOR® Family of 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 Lens (IOL) is 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. The lens is 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. 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. As with other multifocal IOLs, visual symptoms may be significant enough that the patient will request explant of the multifocal IOL. Spectacle independence rates vary with all multifocal IOLs; as such, some patients may need glasses when reading small print or looking at small objects. Clinical studies with the AcrySof® ReSTOR® lens indicated that posterior capsule opacification (PCO), when present, developed earlier into clinically significant PCO. Prior to surgery, physicians should provide prospective patients with a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated 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 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 a complete listing of indications, warnings and precautions.
*With glare (descriptive statistics only).
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1. Henderson B, Solomon K, Masket S, et al. A survey of potential and previous cataract-surgery patients: what the ophthalmologist should know. Clin Ophthalmol. 2014;8:1595-1602.
2. AcrySof® IQ ReSTOR® +2.5 D IOL Directions for Use.
3. Alcon Data on File. CSR C-10-016 (07 Aug 2013).
4. Alcon Data on File. (11 Apr 2016).
5. Alcon Data on File. (06 Oct 2016).
6. Alcon Data on File. (18 Jul 2016).
7. Vega F, Alba-Bueno F, Millán MS, et al. Halo and through-focus performance of four diffractive multifocal and intraocular lenses. Invest Ophthalmol Vis Sci. 2015;56;3967-3975.
8. Alcon Data on File. (19 May 2016).