CORNEAT VISION recalled 180 units of EverPatch+ on August 18, 2025, due to a risk of conjunctival wound dehiscence. This defect may lead to early exposure of the surgical patch. The recall affects distribution across the United States and several countries.
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 EverPatch+, REF: 1044002, with a permanent scleral reinforcement matrix measuring 1x5.0mm x 8.5 mm for the shield and 1 x 5.0mm x 6.5 mm for the rectangle. The product was distributed worldwide, including states across the U.S. and countries like Japan and Israel.
Complaints indicate that conjunctival wound dehiscence may result in early exposure of the surgical patch. This condition poses a significant risk to patients undergoing surgical procedures.
Currently, there are no specific reported incidents associated with injuries or fatalities from this recall. The potential risk is classified as high.
Patients and healthcare providers should immediately stop using the EverPatch+. Follow the recall instructions from CORNEAT VISION, LTD. For guidance, contact the manufacturer or your healthcare provider.
For more information, contact CORNEAT VISION, LTD. via email. Details can be found on the FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0040-2026.
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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.