This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: AcrySof IQ ReSTOR +2.5 D Multifocal Intraocular Lens (IOL), Model SV25T0
PMA Applicant: Alcon Laboratories, Inc.
Address: 6201 South Freeway, Fort Worth, TX 76134
Approval Date: April 13, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/P040020S050a.pdf
What is it? The AcrySof IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0, is an artificial lens. The IOL is implanted inside the eye to replace the natural lens after removal due to clouding (cataract). Cataracts are often the result of aging, but can have other causes.
How does it work? The AcrySof IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0, focuses light inside the eye to provide a range of vision from distance to near.
When is it used? The AcrySof IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0, is used in adult patients, 22 years and older, following cataract surgery.
What will it accomplish? In a clinical study, the AcrySof IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0, was shown to provide distance, intermediate and near vision to patients who have undergone cataract surgery.
When should it not be used? There are no known contraindications.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.
