CORNEAT VISION recalled 180 units of EverPatch+ scleral reinforcement patch worldwide after complaints of conjunctival wound dehiscence. The issue can lead to early exposure of the surgical patch. Clinicians and patients should stop using the device immediately and follow the manufacturer recall instructions.
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 an implant used in ocular surgery to reinforce the sclera. Hospitals and surgeons order it for select patients needing scleral reinforcement. The device is sold worldwide and is sterile.
If conjunctival tissue wounds dehisce, the patch can become exposed, which may require additional surgery or treatment.
This recall is not stated as part of a broader industry pattern.
Patients may experience surgical patch exposure, leading to additional medical intervention and scheduling delays. The recall could affect upcoming procedures and require supplier changes.
Recall notice and FDA enforcement page linked in sources. Manufacturer communications via email.
Refunds or replacements typically processed within 4-8 weeks after manufacturer acknowledgment.
Retain recall notices, emails, and medical records related to the implant and any corrective actions.
Brand: CORNEAT VISION Product: EverPatch+ Permanent Scleral Reinforcement Matrix patch REF: 1044002 UDI: G16010440020 Model: All Lots Quantity: 180 units Sold: Worldwide Recall date: 2025-08-18 Status: ACTIVE Distribution: Worldwide including AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI; Japan, Israel, Argentina, Hong Kong Manufacturer: CORNEAT VISION
No injuries or incidents have been reported.
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