BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171182 · Received September 6, 2024

    Report

    Report Number
    MW5159327
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 30, 2024
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT REVISION SURGERY FOR EXPOSED TUBE SHUNT IN THE LEFT EYE, WHICH INVOLVED COVERING THE TUBE WITH A CORNEAT EVERPATCH AND CLOSING CONJUNCTIVA OVER IT. BY POST-OP WEEK #4, IT WAS NOTED THAT THE CONJUNCTIVA HAD RETRACTED AND EXPOSED THE EVERPATCH. THE PATIENT THEREFORE UNDERWENT ANOTHER REVISION SURGERY ON (B)(6) 2024 TO PREVENT INFECTION, DURING WHICH THE EVERPATCH WAS EXPLANTED AND REPLACED WITH AN IRRADIATED DONOR CORNEAL TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297606 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization