BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON, ENGAUGE

    MDR report key: 16283530 · Received February 2, 2023

    Report

    Report Number
    16283530
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    November 3, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AIMING BEAM WAS WEAK AND NOT RESPONDING PROPERLY, NEW ONE OPENED. HAS BEEN REPORTED TO MANUFACTURER, RGA# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847391 ALCON, ENGAUGE LASER, OPHTHALMIC HQF ALCON LABORATORIES, INC. 8065751593 31479660

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA Female