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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: ACRYSOF® Single-Piece Posterior Chamber Intraocular Lenses With Toric Optic, Models SA60T3, SA60T4 and SA60T5 (ACRYSOF® Toric IOLs)
PMA Applicant: Alcon Research Ltd.
Address: 6201 South Freeway, Fort Worth, TX 76134-2099
Approval Date: September 14, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p930014s015a.pdf
What is it? The ACRYSOF® Toric IOLs are artificial lenses implanted in the eye to restore vision after a clouded natural lens (cataract) is removed.
The lens of the IOL is convex on both sides (biconvex) and made of a soft plastic that can be folded prior to insertion, allowing placement through an incision smaller than the optic diameter of the lens. After surgical insertion into the eye, the lens gently unfolds to restore vision. The supporting arms (haptics) provide for proper positioning of the IOL within the eye.
How does it work? The ACRYSOF® Toric IOL is intended to be positioned in the posterior chamber of the eye, replacing the natural lens. This position allows the IOL to correct the visual impairment of aphakia (absence of the natural lens). The ACRYSOF® Toric IOL has a biconvex optic that is shaped to provide both spherical and astigmatic correction.
When is it used? The ACRYSOF® Toric IOLs are used in adult patients with corneal astigmatism who have undergone cataract removal.
What will it accomplish? The ACRYSOF Toric IOLs have been shown in a clinical study to provide good uncorrected distance in patients who have undergone cataract surgery.
When should it not be used? There are no known contraindications.
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p930014s015