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U.S. Department of Health and Human Services

Medical Devices

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TECNIS Toric 1-Piece Intraocular Lens (IOL) Models: ZCT150, ZCT225, ZCT300, ZCT400 - P980040/S039

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.

Picture of the device
Product Name:  TECNIS Toric 1-Piece Intraocular Lens (IOL)
PMA Applicant: 
Abbott Medical Optics, Inc.
Address: 
1700 East Saint Andrew Place, Santa Ana, CA 92705
Approval Date: April 15, 2013
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf/p980040s039a.pdf

What is it? The TECNIS Toric 1-Piece Intraocular Lens (IOL) is an artificial lens used to correct corneal astigmatism (a football-shaped cornea or an irregularly shaped cornea) and restore distance vision after removal of the natural lens of the eye during cataract surgery. A cataract is a gradual thickening, hardening and clouding of the eye's lens, resulting in loss of vision. Cataracts are often the result of aging, but can have other causes.

How does it work? The TECNIS Toric 1-Piece IOL acts in place of the healthy eye lens to correctly focus light on the retina and restore vision. The TECNIS Toric 1-Piece IOL has a lens that is shaped to correct both irregularities to the shape of the eye and the shape of the cornea.

When is it used? The TECNIS Toric 1-Piece IOL is used to restore vision in adult patients with corneal astigmatism and a cataract.

What will it accomplish? The TECNIS Toric 1-Piece IOL has been shown in a clinical study to provide good uncorrected distance vision in 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.