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U.S. Department of Health and Human Services

Medical Devices

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Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) - P110007

Picture of the device.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: Healon® EndoCoat Ophthalmic Viscosurgical Device
PMA Applicant:
Abbott Medical Optics Inc.
Address:
1700 E. St. Andrews Place, Santa Ana, CA 92705
Approval Date:
July 2, 2012
Approval Letter:
http://www.accessdata.fda.gov/ cdrh_docs/pdf11/p110007a.pdf

What is it? Healon® EndoCoat Ophthalmic Viscosurgical Device (OVD) is made of sodium hyaluronate, a clear, thick liquid.

How does it work? It is injected from a syringe into the patient’s eye to protect and coat the eye’s tissues during surgery.

When is it used? The Healon® EndoCoat OVD is used during surgery in the front part of the eye, including cataract surgery (surgery to remove the natural lens that has become cloudy and difficult to see through) and intraocular lens (IOL) implantation.

What will it accomplish? The Healon® EndoCoat OVD will help prevent tissue damage during surgery, including significant loss of endothelial cells. These cells line the back of the cornea (the clear tissue that covers the front of the eye) and keep it clear by pumping fluid out. Without enough of these cells, the cornea becomes cloudy and vision is lost.

When should it not be used? When used as recommended, there are no known conditions when this product should not be used.

Additional Information: The Summary of Safety and Effectiveness Data and labeling are available online.