BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERPATCH

    MDR report key: 22919450 · Received August 28, 2025

    Report

    Report Number
    3029772936-2025-00004
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    July 29, 2025
    Report Date
    August 28, 2025
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. THE EXPLANTED DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE FOR EVALUATION. THE CURRENT DEVICE INSTRUCTIONS FOR USE IDENTIFIES THE FOLLOWING POSSIBLE COMPLICATIONS: "DETACHMENT OF THE DEVICE FROM SURROUNDING TISSUE IN CASE OF TRAUMA OR WHEN CHRONIC INFLAMMATION IS NOT ADDRESSED"; AND "CONJUNCTIVAL RETRACTION OR WOUND DEHISCENCE, WHICH MAY LEAD TO EXPOSURE OF THE DEVICE AND COULD REQUIRE A CORRECTIVE PROCEDURE". THE CURRENT INSTRUCTIONS FOR USE ALSO RECOMMENDS "IN THE SHORT TERM AFTER SURGERY, MORE FREQUENT FOLLOW-UP VISITS SHOULD BE CONDUCTED TO ENSURE PROPER WOUND HEALING." MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON JULY, 22, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. NO MIGRATION OF THE PATCH WAS OBSERVED AND THE WOUND WAS SEIDEL NEGATIVE (I.E., NO WOUND LEAK). THE PATIENT WAS BEING OBSERVED AND THE NEXT FOLLOW-UP VISIT WAS SCHEDULED FOR (B)(6) 2025. ON JULY 31, 2025, THE SURGEON PROVIDED THE FOLLOWING EVENT INFORMATION: ON (B)(6) 2025 THE PATIENT UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) IN THE LEFT EYE AND THE CORNEAT EVERPATCH WAS IMPLANTED IN THE SUPERIOR TEMPORAL QUADRANT. A FORNIX-BASED FLAP WAS USED AND NO CAUTERY OR MITOMYCIN-C (MMC) WAS APPLIED. VICRYL SUTURES WERE USED TO SUTURE THE EVERPATCH TO THE SCLERA AND INTERRUPTED VICRYL SUTURES WERE USED TO CLOSE THE CONJUNCTIVAL WOUND. POSTOPERATIVELY THERE WAS NO LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY. ON (B)(6) 2025, A CORRECTIVE PROCEDURE WAS PERFORMED WHERE THE EVERPATCH WAS EXPLANTED AND INVOLVED DISSECTION OF CONJUNCTIVAL GROWTH UNDERNEATH THE PATCH. THE AGV WAS THEN COVERED WITH TUTOPLAST PROCESSED SCLERA AND COVERED WITH ROTATIONAL CONJUNCTIVAL FLAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235903 EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20240602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention AHMED GLAUCOMA VALVE.