BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171206 · Received September 6, 2024

    Report

    Report Number
    MW5159328
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CORNEAT VISION LDT
    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 GLAUCOMA TUBE SHUNT IMPLANTATION IN THE RIGHT EYE ON (B)(6) 2024 WITH USE OF CORNEAT EVERPATCH TO COVER THE TUBE. CONJUNCTIVAL RETRACTION WITH EXPOSURE OF THE EVERPATCH WAS NOTED AT POW12. THE PATIENT WAS ALREADY SCHEDULED FOR PANRETINAL LASER PHOTOCOAGULATION IN THE OPERATING ROOM FOR TREATMENT OF DIABETIC RETINOPATHY (UNRELATED) AND SO DECISION WAS MADE TO REVISE THE TUBE SHUNT AT THAT TIME BY EXPLANTING THE CORNEAT EVERPATCH AND REPLACING WITH IRRADIATED DONOR CORNEA. THIS SURGERY HAS NOT YET TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297607 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION LDT 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other