BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORNEAT EVERPATCH

    MDR report key: 19370667 · Received May 22, 2024

    Report

    Report Number
    3029772936-2024-00002
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    April 24, 2024
    Report Date
    November 11, 2024
    Manufacturer
    CORNEAT VISION, LTD.
    Product Code
    QWU
    UDI-DI
    G16010362950
    PMA / PMN Number
    K223074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVERPATCH REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER. THE DEVICE IDENTIFIERS WERE PROVIDED, AND THE LOT HISTORY RECORDS WERE REVIEWED. THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. THE ROOT CAUSE INVESTIGATION IS UNDERWAY AND THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT GLAUCOMA SURGERY ON (B)(6) 2024 WITH IMPLANTATION OF A BAERVELDT GLAUCOMA IMPLANT WHERE THE CORNEAT EVERPATCH WAS USED TO REINFORCE THE SCLERA AND AID THE PHYSICAL RECONSTRUCTION OF THE OCULAR SURFACE. DURING SURGERY, THE EVERPATCH WAS NOT VISIBLE WHICH MADE IT DIFFICULT TO PERFORM LASER LYSIS. ONE DAY POSTOPERATIVELY THE PATIENT PRESENTED WITH AN INTRAOCULAR PRESSURE (IOP) OF 50 MMHG. ON (B)(6) 2024, THE BAERVELDT DEVICE WAS EXPLANTED AND REPLACED WITH AN AHMED GLAUCOMA SHUNT. FOLLOW-UP WAS REQUESTED FROM THE SURGEON WHO REPORTS THE PATIENT MAY HAVE LOST VISION. ADDITIONAL FOLLOW-UP WILL BE REQUESTED.

    Description of Event or Problem · 0

    ADDITIONAL PATIENT FOLLOW-UP WAS REQUESTED FROM THE SURGEON ON AUGUST 29, 2024, SEPTEMBER 5, 2024, AND SEPTEMBER 8, 2024, WITH NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704714 CORNEAT EVERPATCH PROSTHESIS, EYELID SPACER/GRAFT, POLYMER QWU CORNEAT VISION, LTD. 1007691 20230713 G16010362950

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention BAERVELDT GLAUCOMA IMPLANT.