CorNeat EverPatch (CorNeat) – Labeling Correction (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Brand
CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel
Lot Codes / Batch Numbers
UDI-DI: G16010362950
Products Sold
UDI-DI: G16010362950
CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel is recalling CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 due to Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026