BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 20566087 · Received October 30, 2024

    Report

    Report Number
    20566087
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    April 2, 2024
    Report Date
    October 3, 2024
    Manufacturer
    CORNEAT VISION LTD
    Product Code
    QWU
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OVER THE PAST 6 MONTHS, 3 DIFFERENT OPHTHALMOLOGY DOCTORS HAVE PERFORMED A TOTAL OF 29 TUBE SHUNT IMPLANTATION SURGERIES USING THE CORNEAT EVERPATCH TO COVER THE TUBE. THIS IS AN FDA 510(K) CLEARED DEVICE MARKETED FOR USE IN CONJUNCTION WITH GLAUCOMA TUBE SHUNT IMPLANTATION OR TUBE REVISION PROCEDURES. AMONGST THIS COHORT OF PATIENTS, WE HAVE OBSERVED CONJUNCTIVAL RETRACTION AND EROSION WITH EXPOSURE OF THE EVERPATCH IN 9 PATIENTS (31%). OF THOSE, 4 HAVE COMPLETED OR ARE SCHEDULED FOR REVISION SURGERY DUE TO EITHER DISLOCATION OF THE EVERPATCH ONTO THE CORNEAL SURFACE OR PROGRESSIVELY INCREASING EXPOSURE OF THE EVERPATCH WITHOUT EPITHELIALIZATION. THIS RATE OF CONJUNCTIVAL RETRACTION AND PATCH EXPOSURE (REQUIRING RETURN TO OR [OPERATING ROOM]) IS DRAMATICALLY HIGHER THAN WHAT WE HAVE BEEN SEEING PREVIOUSLY WITH SPLIT THICKNESS CORNEAL HALF-MOON PATCH GRAFTS OR TUTOPLAST GRAFTS, AND WE ARE CONCERNED THERE MAY BE A PROBLEM WITH USING THIS DEVICE AS A PATCH FOR TUBE SHUNT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965714 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION LTD 1007691 20230713

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female