BEUDAMED
    FDA Recall Open, Classified

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

    Recall: Z-2537-2025 · Initiated October 16, 2024

    Recall

    Recall Number
    Z-2537-2025
    Event Number
    97281
    Firm
    CORNEAT VISION, LTD. 4, Ha-Sheizaf Ra'Anana Israel
    FEI Number
    3029772936
    Product Code
    QWU
    Status
    Open, Classified
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    October 16, 2024
    Posted
    September 5, 2025

    Description

    CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only

    Reason

    Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.

    Action

    On October 16-17, 2024, Corneat Vision provided customers with an email containing important information concerning the device safety and efficacy related CorNeat EverPatch. Customers were informed that the IFUs were modified to include conditions that may impair healing and reduce he effectiveness of the EverPatch. Surgical practices were advised to maximize success rate.

    Distribution

    Worldwide - US Nationwide distribution in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Argentina, Israel, Hong Kong.