CorNeat EverPatch Surgical Matrix Labeling Correction for Wound Dehiscence
The FDA is correcting labeling for CorNeat EverPatch surgical matrices to include prevention and management guidance for wound dehiscence. This Class II recall addresses gaps in product instructions following complaints.
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 medical device recall addressing labeling gaps for wound dehiscence prevention and management in a surgical matrix. While specific injury reports are not explicitly stated, the complaints triggering this retroactive labeling correction indicate real-world adverse events, qualifying this as a risk-of-harm medical device scenario.
Plain-English summary
The FDA is issuing a Class II recall of CorNeat EverPatch (REF: 1036295), a permanent tissue-integrating surgical matrix used in ophthalmic procedures. The recall is retroactive and addresses a labeling deficiency: the original product labeling did not adequately cover prevention and management of wound dehiscence, a surgical complication where the incision site separates or reopens.
Due to complaints, the manufacturer is correcting the labeling to include necessary guidance on preventing and managing wound dehiscence with this surgical matrix.
CorNeat EverPatch has been distributed in 28 U.S. states and territories, as well as internationally to Argentina, Israel, and Hong Kong. The product is identified by UDI-DI: G16010362950.
Healthcare providers using this device should review the corrected labeling when available to ensure proper wound management protocols are followed during and after surgical procedures using this matrix.
The recalled product
- Product
- CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
- Manufacturer
- CORNEAT VISION, LTD.
- Hazard
- wound-dehiscence
- labeling-deficiency
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)
- UDI-DI: G16010362950
Distribution
Distributed nationwide across the United States.
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