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: ClearVisc Ophthalmic Viscosurgical Device (OVD)
PMA Applicant: Bausch Health
Address: 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807
Approval Date: March 23, 2021
Approval Letter: Approval Order
What is it?
ClearVisc Ophthalmic Viscosurgical Device (OVD) is a transparent thick liquid used to protect eye tissue during eye surgery, including cataract surgery. It is made with sodium hyaluronate, a chemical component that makes ClearVisc thick. Sodium hyaluronate is a type of salt naturally found inside the body.
How does it work?
The OVD liquid is injected into the eye, using a syringe, to protect eye tissues and prevents the loss of endothelial cells. The OVD liquid coats the tissues and provides cushioning to minimize damage during surgery. Endothelial cells control the amount of fluid in the cornea, which is the clear tissue that covers the front of the eye. These cells line the back of the cornea and pump fluid out.
When is it used?
ClearVisc OVD is used during eye surgery, such as cataract surgery, when the natural lens of the eye becomes cloudy and difficult to see through.
What will it accomplish?
The OVD helps prevent tissue damage during eye surgery, including preventing significant loss of endothelial cells.
When should it not be used?
There are no known conditions when ClearVisc should not be used.