BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERPATCH

    MDR report key: 23049356 · Received September 15, 2025

    Report

    Report Number
    3029772936-2025-00005
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    February 28, 2024
    Report Date
    September 15, 2025
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010362950
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    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 EXTRUDED DEVICE WAS NOT AVAILABLE FOR EVALUATION. THE INSTRUCTIONS FOR USE EFFECTIVE AT THE TIME OF USE INCLUDED A CONTRAINDICATION STATING THE "CORNEAT EVERPATCH SHOULD NOT BE USED IN SURGICAL SITES WHERE ACTIVE INFLAMMATION OF ANY CAUSE IS PRESENT, OR SITES WITH POOR PERFUSION." IMPLANTATION OF THE CORNEAT EVERPATCH WAS CONTRAINDICATED IN THIS PATIENT BASED ON THEIR HISTORY OF POOR OCULAR SURFACE WOUND HEALING. 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". MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    ON AUGUST 18, 2025, CORNEAT RECEIVED NOTIFICATION OF A CASE OF WOUND DEHISCENCE INVOLVING THE CORNEAT EVERPATCH. A PATIENT WITH A HISTORY OF NEOVASCULAR GLAUCOMA, DIABETES, AND POOR OCULAR SURFACE WOUND HEALING UNDERWENT IMPLANTATION OF AN AHMED GLAUCOMA VALVE (AGV) ON (B)(6) 2023. THE PATIENT SUBSEQUENTLY REQUIRED AGV REVISION SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE AGV WAS EXPLANTED AND REPLACED WITH AN AHMED CLEARPATH GLAUCOMA DRAINAGE DEVICE WHICH WAS COVERED WITH A CORNEAT EVERPATCH. APPROXIMATELY ONE MONTH FOLLOWING IMPLANTATION OF CORNEAT EVERPATCH, THE CONJUNCTIVAL WOUND DEHISCED, AND THE CORNEAT EVERPATCH SPONTANEOUSLY EXTRUDED FROM THE EYE. THE PATIENT WAS TREATED WITH A TOPICAL ANTIBIOTIC. NO SURGICAL REVISION WAS PERFORMED. NO PERMANENT IMPAIRMENT, INCLUDING VISION LOSS, WAS OBSERVED DURING THE 18-MONTH POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778608 EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention AHMED CLEARPATH GLAUCOMA DRAINAGE DEVICE