CorNeat Vision recalled 630 units of the EverPatch surgical matrix on August 18, 2025. The recall follows complaints of conjunctival wound dehiscence leading to potential exposure of the surgical patch. The product was distributed worldwide, including across numerous U.S. states.
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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 CorNeat EverPatch, REF: 1036295. The dimensions are 5.0 mm x 605 mm x 100 µm. It was distributed in the U.S. and other countries.
The recall stems from reports indicating that conjunctival wound dehiscence may occur, which could lead to early exposure of the surgical patch. This presents a significant risk to patients undergoing surgery.
The recall does not specify exact numbers of reported incidents related to injuries. No deaths have been reported.
Patients and healthcare providers should stop using this device immediately. Contact CorNeat Vision, Ltd. or your healthcare provider for further instructions.
For more information, email CorNeat Vision, Ltd. at the address provided in the recall notification.
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CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.