BEUDAMED
    FDA Enforcement Class II Ongoing

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

    Recall: Z-0039-2026 · Reported October 15, 2025

    Enforcement

    Recall Number
    Z-0039-2026
    Event ID
    97463
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    CORNEAT VISION, LTD.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 15, 2025
    Initiation Date
    August 18, 2025
    Classification Date
    October 3, 2025
    Address
    4, Ha-Sheizaf, Ra'Anana, N/A, Israel

    Description

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m

    Reason

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

    Code Info

    All Lots/ UDI: G16010362950

    Distribution

    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.

    Quantity

    630 units