BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171904 · Received September 6, 2024

    Report

    Report Number
    MW5159337
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 13, 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 IMPLANTATION OF GLAUCOMA TUBE SHUNT SURGERY IN THE LEFT EYE ON (B)(6) 2024 AND A CORNEAT EVERPATCH WAS USED TO COVER THE TUBE SHUNT. ON (B)(6) 2024 SHE DEVELOPED OCULAR DISCOMFORT AND LOOKED IN THE MIRROR AND SAW THE EVERPATCH HAD DISLOCATED ANTERIORLY AND WAS PARTIALLY COVERING HER CORNEA. SHE PRESENTED TO THE EMERGENCY ROOM FOR THIS AND THEN WAS SCHEDULED FOR URGENT TUBE SHUNT REVISION WHICH TOOK PLACE ON (B)(6) 2024 TO PREVENT INFECTION/ENDOPHTHALMITIS. THIS WAS DONE BY EXPLANTING THE EVERPATCH AND REPLACING IT WITH AN IRRADIATED CORNEAL PATCH AND CLOSING THE CONJUNCTIVA OVER IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329911 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1036295 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Hospitalization