BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 12677653 · Received October 21, 2021

    Report

    Report Number
    2939653-2021-00019
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 15, 2021
    Product Code
    HQF
    UDI-DI
    00813125016555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IRIDEX BECAME AWARE OF A COMPLAINT REPORTING A CASE OF MYDRIASIS FOLLOWED BY BLURRY VISION POST TREATMENT USING A CYCLO G6 CONSOLE WITH A MICROPULSE P3 PROBE. MYDRIASIS IS A CONDITION WHERE THE PUPIL OF THE EYE IS FIXED AND DILATED. THE DOCTOR WAS A NEW IRIDEX DEVICE USER. THE PROCEDURE WAS INTENDED BY AN IRIDEX REPRESENTATIVE WHO CONFIRMED THAT TREATMENT SETTINGS WERE WITHIN SPECIFICATION AND THE DOCTOR USED A GOOD TECHNIQUE. THIS COMPLAINT DID NOT INVOLVE ANY REPORT OF MALFUNCTION OF THE LASER CONSOLE AND PROBE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567843 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF 66245 00813125016555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other