CorNeat Vision recalled the CorNeat EverPatch surgical matrix on October 16, 2024. The recall affects the product's labeling for prevention and management of wound dehiscence. Distribution spans across the U.S. and several countries.
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CORNEAT VISION, LTD. or your healthcare provider for instructions. Notification method: E-Mail
The recalled product is the CorNeat EverPatch with REF: 1036295. It measures 5.0 mm x 6.5 mm x 100 um and is classified as RX only. It has been distributed worldwide, including states such as CA, FL, NY, and internationally in Argentina and Israel.
The recall was initiated due to complaints regarding the effectiveness of the product. The labeling correction is necessary to include information on preventing and managing wound dehiscence.
There are no specific reported incidents or injuries related to this recall. The recall is precautionary in nature.
Patients and healthcare providers should stop using the CorNeat EverPatch immediately. Follow the recall instructions provided and contact CORNEAT VISION, LTD. or your healthcare provider for further guidance.
For more information, contact CORNEAT VISION, LTD. via email or visit their website. Additional details are available at the FDA recall page.
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