BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCON DIODE LASER 635NM 1MW

    MDR report key: 21832248 · Received April 14, 2025

    Report

    Report Number
    21832248
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 12, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ALCON
    Product Code
    HQF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DIODE LASER WOULD NOT WORK DURING PROCEDURE. ALCON REPRESENTATIVE CONTACTED AND ASSISTED WITH TROUBLESHOOTING FOR OVER AN HOUR WITHOUT SUCCESS. PROVIDER DECIDED TO COMPLETE PROCEDURE, SEND PATIENT TO PACU [POST ANESTHESIA RECOVERY UNIT], AND THEN SEE PATIENT IN OFFICE AND USE OFFICE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006991 ALCON DIODE LASER 635NM 1MW LASER, OPHTHALMIC HQF ALCON 635NM-1MW

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female