BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA FLOW

    MDR report key: 22698159 · Received August 4, 2025

    Report

    Report Number
    22698159
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    NKK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TOWARDS THE END OF THE SURGICAL PROCEDURE, THE SURGEON NOTICED METALLIC SHAVINGS WITHIN THE PATIENT'S ANTERIOR CHAMBER OF THE EYE. AT THIS POINT, THE SURGEON PAUSED THE SURGERY AND COMMENCED TO REMOVE THE METAL SHAVINGS FROM WITHIN THE PATIENT'S EYE. ALL METAL SHAVINGS THAT WERE VISIBLE TO THE SURGEON UNDER THE MICROSCOPE WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230209 ULTRA FLOW NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED NKK ALCON LABORATORIES, INC. 8065751795 16DX0U

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female