CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
FDA Recall Z-2537-2025 · Posted 2025-09-05
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Recalling FirmCORNEAT VISION, LTD.
Recall StatusOpen, Classified
Product CodeQWU
Date Initiated2024-10-16
Reason for Recall
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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