BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 18375220 · Received December 21, 2023

    Report

    Report Number
    1000125279-2023-00031
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    March 8, 2023
    Report Date
    January 17, 2024
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    UDI-DI
    00892064002119
    PMA / PMN Number
    K230975
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS EVALUATED IN COMPLIANCE WITH NWM PROCEDURES. NO ISSUES WERE FOUND DURING VISUAL INSPECTION. THE DEVICE WAS TESTED FOR STEADY STATE PRESSURE AND WAS FOUND TO FUNCTION WITHIN SPECIFICATION. THE REPORTED ISSUE OF LOW IOP COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    DHR FOR THE REPORTED LOT WAS REVIEWED WITH NO ISSUES FOUND. PRODUCT WAS MANUFACTURED, TESTED, AND RELEASED IN COMPLIANCE WITH NWM PROCEDURES. DEVICE PENDING EVALUATION. AN ADDENDUM WILL BE FILED WITH EVALUATION RESULTS ONCE AVAILABLE.

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED "NO VALVE EFFECT WITH LOW IOP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287826 AHMED GLAUCOMA VALVE GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC. FP7 J0122 00892064002119

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other