CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
This recall is currently active, issued September 5, 2025. It was issued by Corneat Vision, Ltd. 4, Ha-Sheizaf Ra'Anana Israel.
- Recall Initiated
- October 16, 2024
- Posted
- September 5, 2025
- Recall Number
- Z-2537-2025
- Official Source
- View on FDA website ↗
Reason for Recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Distribution
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.
Lot / Code Info
UDI-DI: G16010362950
Root Cause
Unknown/Undetermined by firm
Action Taken
On October 16-17, 2024, Corneat Vision provided customers with an email containing important information concerning the device safety and efficacy related CorNeat EverPatch. Customers were informed that the IFUs were modified to include conditions that may impair healing and reduce he effectiveness of the EverPatch. Surgical practices were advised to maximize success rate.