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U.S. Department of Health and Human Services

Class 2 Device Recall CorNeat EverPatch

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 Class 2 Device Recall CorNeat EverPatchsee related information
Date Initiated by FirmOctober 16, 2024
Date PostedSeptember 05, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2537-2025
Recall Event ID 97281
510(K)NumberK223074 
Product Classification Prosthesis, eyelid spacer/graft, polymer - Product Code QWU
ProductCorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
Code Information UDI-DI: G16010362950
FEI Number 3029772936
Recalling Firm/
Manufacturer		 CORNEAT VISION, LTD.
4, Ha-Sheizaf
Ra'Anana Israel
Manufacturer Reason
for Recall		Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionOn 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.
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = QWU
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