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U.S. Department of Health and Human Services

Medical Devices

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Trulign Toric Posterior Chamber Intraocular Lens and Trulign Toric IOL Calculator - P030002/S027

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: Trulign Toric Posterior Chamber Intraocular Lens and Trulign Toric IOL Calculator
PMA Applicant: Bausch + Lomb
Address: 30 Enterprise
Aliso Viejo, CA 92656
Approval Date: May 20, 2013
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030002S027a.pdf

What is it? The Trulign Toric Posterior Chamber Intraocular Lens (IOL)disclaimer icon is an artificial lens. It is used restore vision after removal of the eye’s natural lens during cataract surgery. In addition, it corrects blurry vision due to corneal astigmatism (football shape to the cornea).

A cataract is a gradual 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 Trulign Toric IOL is used to replace the natural lens that has a cataract to correctly focus light on the retina and restores vision. The Trulign Toric IOL is a lens that is designed to correct blurred vision due to the shape of the cornea.

When is it used? The Trulign Toric IOL is used in adult patients with a cataract who also have corneal astigmatism.

What will it accomplish? The Trulign Toric IOL has been shown in a clinical study to provide uncorrected near, intermediate, and 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.