FDAHealthAugust 18, 2025
CORNEAT VISION, LTD. — CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
⚠️ 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
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
- Brand
- CORNEAT VISION, LTD.
- Lot code
- /
Additional details
All Lots/ UDI: G16010362950
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 630 units.
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