BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171409 · Received September 6, 2024

    Report

    Report Number
    MW5159333
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CORNEAT VISION, LTD
    Product Code
    QWU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT SURGERY ON THE RIGHT EYE ON (B)(6) 2024. THE SURGERY INVOLVED COVERING OF EXPOSED GORE-TEX SUTURE ON THE OCULAR SURFACE, WHICH WERE PRESENT TO HOLD A SCLERAL SUTURED IOL (INTRAOCULAR LENSES) IN PLACE. THE SUTURES HAD ERODED THROUGH CONJUNCTIVA. THE SURGERY INVOLVED COVERING THE SUTURES WITH A CORNEAT EVERPATCH AND THEN CLOSING THE CONJUNCTIVA OVER IT. THE PATIENT WAS NOTED TO HAVE CONJUNCTIVAL RETRACTION AND EXPOSURE OF THE EVERPATCH AT POW7 (POST-OP WEEK#7). THE PATIENT IS CURRENTLY BEING OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329907 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other