BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20171887 · Received September 6, 2024

    Report

    Report Number
    MW5159336
    Event Type
    Injury
    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 HAD GLAUCOMA TUBE SHUNT IMPLANTATION ON (B)(6) 2024 WITH USE OF CORNEAT EVERPATCH TO COVER THE TUBE. AT POW 4.5 THERE WAS NOTED TO BE CONJUNCTIVAL RETRACTION AND EXPOSURE OF THE CORNEAT EVERPATCH. IN ADDITION HE HAS PERSISTENT VITREOUS HEMORRHAGE (NOT RELATED TO THE EVERPATCH) FOR WHICH HE IS SCHEDULED TO HAVE PARS PLANA VITRECTOMY ON (B)(6) 2024, AND SO THE TUBE WILL BE REVISED AT THE SAME TIME BY EXPLANTING THE EVERPATCH AND REPLACING IT WITH IRRADIATED CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329910 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION LTD 1036925 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization