Ocular surgical matrix recalled after complaints of early patch exposure
CorNeat Vision is recalling 630 CorNeat EverPatch units after reviewed complaints identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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: Scored 3 under the risk-of-harm criterion: complaints identify early exposure of an implanted ocular patch, a clinical risk with no injury count stated.
Plain-English summary
The CorNeat EverPatch, REF 1036295, a permanent tissue-integrating surgical matrix measuring 5.0 mm x 605 mm x 100 micrometres, is being recalled.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
The recall covers 630 units across all lots, UDI G16010362950, distributed worldwide including in Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas and Massachusetts among other states. The FDA has classified the action as Class II.
Surgeons and facilities holding the product should follow CorNeat Vision's instructions.
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.
- Affected units
- 630
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
Part of a larger recall action
This product is one of 2 recalled by CORNEAT VISION, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · CORNEAT VISION, LTD.
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