FDAHealthAugust 18, 2025
CORNEAT VISION, LTD. — EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
⚠️ Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 18, 2025
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Japan, Israel, Argentina, Hong Kong.
What's affected?
- Product
- EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
- Brand
- CORNEAT VISION, LTD.
- Lot code
- /
Additional details
All Lots/ UDI: G16010440020
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 180 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.