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New Device Approval

(illustration of device)Hoya iSpheric™ Model YA-60BB Intraocular Lens - P080004

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: Hoya iSpheric™ Model YA-60BB Intraocular Lens
PMA Applicant: Hoya Surgical Optics, Inc.
Address: 14768 Pipeline Avenue, Chino Hills, CA 91709
Approval Date: September 26, 2008
Approval Letter: http://www.fda.gov/cdrh/pdf8/p080004a.pdf

What is it? The Hoya iSpheric™ Model YA-60BB IOL is a plastic lens used to restore vision and replace the natural lens of the eye after it is removed 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 Hoya iSpheric™ Model YA-60BB IOL acts as a healthy eye lens to correctly focus light on the retina and restore vision.

When is it used? The Hoya iSpheric™ Model YA-60BB IOL is used to restore vision in adult patients who have had a cataract removed.

What will it accomplish? The Hoya iSpheric™ Model YA-60BB IOL restores mostly distance vision by acting as a substitute for the removed natural lens; however, this artificial lens does not have the ability to focus on near targets (accommodation).

When should it not be used? The Hoya iSpheric™ Model YA-60BB IOL should not be implanted when the IOL may make worse an existing condition, interfere with the diagnosis or the treatment of a condition, or present a risk to the sight of the patient.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf8/p080004.html

Other:

Updated October 2, 2008

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