BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 11859882 · Received May 20, 2021

    Report

    Report Number
    1000125279-2021-00006
    Event Type
    Injury
    Date Received
    May 20, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 23, 2021
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE FROM DOCTOR STATES THAT THE VALVE WILL REMAIN IN PATIENT AND ACT AS A VALVELESS GLAUCOMA DRAINAGE DEVICE; THEREFORE, IT WILL NOT BE AVAILABLE FOR EVALUATION. PATIENT SUFFERED FROM HYPHEMA AND REQUIRED 3 TREATMENTS IN CLINIC TO MAINTAIN PRESSURE. AFTER THE THIRD TREATMENT, THE PATIENT'S PRESSURE STABILIZED.

    Description of Event or Problem · 0

    POSTOPERATIVE OVER-FILTRATION OF TUBE SHUNT RESULTED IN SHALLOW ANTERIOR CHAMBER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT INVOLVED WAS REVIEWED AND NO ISSUES WERE OBSERVED. PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED PER VALIDATED PROCEDURES. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    POSTOPERATIVE OVER-FILTRATION OF TUBE SHUNT RESULTED IN SHALLOW ANTERIOR CHAMBER AND NEED FOR REFORMING ANTERIOR CHAMBER WITH VISCOELASTIC THREE TIMES POSTOPERATIVELY; ALSO RESULTED IN EXTENDED PRESENCE OF CHOROIDAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751952 AHMED GLAUCOMA VALVE FP7 KYF NEW WORLD MEDICAL, INC. FP7 M0220 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention