CorNeat EverPatch Surgical Matrix Recalled for Potential Early Tissue Exposure
CorNeat EverPatch surgical patches are recalled due to risk of early exposure caused by conjunctival wound separation. The FDA identified the issue through complaint review.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device with a theoretical risk of surgical patch exposure due to wound dehiscence. No deaths, injuries, or hospitalizations have been reported; the hazard is based on complaint review identifying the potential risk.
Plain-English summary
CorNeat EverPatch is a permanent tissue-integrating surgical matrix measuring 5.0 mm x 605 mm x 100 μm, manufactured by CorNeat Vision, Ltd. The recall involves 630 units with UDI G16010362950.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. Wound dehiscence refers to the separation of the surgical incision after implantation.
The product was distributed worldwide, including throughout the United States and internationally in Japan, Israel, Argentina, and Hong Kong.
Patients who have received this implant should contact their healthcare provider with any concerns. Healthcare providers managing patients with this implant should contact the manufacturer or the FDA for guidance.
The recalled product
- Product
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
- Manufacturer
- CORNEAT VISION, LTD.
- Hazard
- wound-dehiscence
- surgical-patch-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI: G16010362950
Distribution
Distributed nationwide across the United States.
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