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RecallWatchMedical Device Safety
Class IIOngoingZ-0039-2026

CORNEAT VISION, LTD. recalls CorNeat EverPatch

CORNEAT VISION, LTD.Ra'Anana, IsraelReported Oct 15, 2025 · 9 months ago
Legal News Analyst ·

Reason for recall

Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
    UDI G16010362950
    Affected lot
    G16010362950

What the firm is doing

On August 18, 2025, CorNeat Vision, Ltd. issued a "Urgent: Medical Device Recall" Notification to affected consignees via E-Mail. CorNeat ask consignees to take the following actions: 1. Review inventory, Quarantine and Discontinue use of All Lots of the CorNeat EverPatch and/or EverPatch+. 2. Please discard any unused product. 3. Eyecare providers should continue to monitor patients who have had CorNeat EverPatch and/or EverPatch+ implanted at the follow-up frequency necessary to detect signs of wound dehiscence or conjunctival thinning/erosion. 4. Patients should be instructed to seek prompt follow-up if they experience any signs or symptoms consistent with this complication. 5. This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 6. Please fill in the MEDICAL DEVICE RECALL RETURN RESPONSE form at www.corneat.com/everpatch-recall or fill in the attached form and forward to CorNeat Vision by email to complaints@corneat.com .

DistributionShow details

Worldwide - US Nationwide distribution in the states of 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 and the countries of Japan, Israel, Argentina, Hong Kong.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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