BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

    MDR report key: 12677628 · Received October 21, 2021

    Report

    Report Number
    2939653-2021-00018
    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. IN THIS CASE THE PATIENT WAS HIGHLY MYOPIC. IN CASES WHERE THE PATIENT IS HIGHLY MYOPIC IT CAN BE DIFFICULT TO DISTINGUISH THE REGION OF THE LIMBUS. THIS MAY RESULT IN THE PROBE BEING POSITIONED INCORRECTLY (E.G. POSITIONED TOO ANTERIOR). IF TREATMENT WAS PERFORMED IN THE INCORRECT LOCATION, THIS COULD BE A CONTRIBUTING FACTOR TO THE OBSERVED RESULT. 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
    1567842 LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF HQF 66245 00813125016555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other