CorNeat Vision recalled 630 EverPatch surgical matrices distributed worldwide, including in 28 U.S. states. Review of complaints found conjunctival wound dehiscence may lead to early exposure of the patch. Stop using the device immediately and follow the manufacturer’s recall instructions. Contact CORNEAT VISION, LTD. or your healthcare provider for guidance.
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
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EverPatch is a surgical matrix intended to aid tissue integration during ocular procedures. It is used by surgeons in the operating room under medical supervision.
If the conjunctival wound dehisces, the patch could become exposed prematurely, potentially complicating healing and necessitating additional procedures.
This recall is not described as part of a broader industry pattern.
The recall may disrupt planned surgeries and require patients to undergo follow-up interventions. The issue creates safety and operational uncertainty for treatment teams.
UDI appears on the device labeling and patient device cards; the FDA recall page provides official details
Replacement or refund timelines typically 4-8 weeks after confirmation
Retain all recall notices, correspondence with the manufacturer, and any medical records related to the affected device
Model numbers: All Lots/ UDI: G16010362950. Sold worldwide through healthcare distributors and providers. Sold since: Unknown. Price: Unknown. Quantity: 630 units.
No injuries or incidents have been reported.
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