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: StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
PMA Applicant: Bausch Health Companies, Inc.
Address: 400 Somerset Corporate Boulevard, Bridgewater, NJ 08807
Approval Date: February 22, 2023
Approval Letter: Approval order
What is it?
StableVisc Ophthalmic Viscosurgical Device (OVD) is a transparent thick liquid used during eye surgery when the natural lens of the eye has become cloudy and difficult to see through (cataract surgery). The StableVisc OVD protects the eye tissues.
TotalVisc OVD includes multiple products in one package: An individually wrapped syringe of StableVisc OVD co-packaged with an individually wrapped syringe of the previously approved ClearVisc OVD. This approval reviewed information for the StableVisc OVD only.
How does it work?
StableVisc OVD is injected from a syringe into the eye during cataract surgery.
When is it used?
StableVisc OVD is used during surgery in the front part of the eye, including cataract surgery.
What will it accomplish?
StableVisc OVD helps 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.
A study comparing the safety and effectiveness of StableVisc OVD to a similar already approved OVD found that the average loss of endothelial cells three months after cataract surgery was not significantly worse for people who received StableVisc OVD during surgery (17.5 for every 100 cells) when compared to those who received the already approved device (16.9 for every 100 cells).
When should it not be used?
There are no known reasons not to use StableVisc as an aid during surgery in the front part of the eye.
Additional information (including warnings, precautions, and adverse events)
- Summary of Safety and Effectiveness Data (SSED)
- StableVisc Labeling
- TotalVisc Labeling (Labeling part 2)
- PMA Database entry