BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAQ REFLEX

    MDR report key: 18279406 · Received December 6, 2023

    Report

    Report Number
    3002806902-2023-00003
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    October 17, 2023
    Report Date
    December 6, 2023
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000427
    PMA / PMN Number
    K212630
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE PROBLEM WHICH COULD HAVE LED TO THE EVENT. THE DEVICE WAS VERIFIED AFTER THE EVENT , AND IT WAS WITHIN SPECIFICATIONS ALTHOUGH THERE WERE CERTAIN ADJUSTMENTS DONE TO IMPROVE THE PERFORMANCE. THE USER HAD PERFORMED LASER FLOATER TREATMENT ON THE PATIENT . THE THIRD PULSE CAUSED IMMEDIATE VITREOUS HEMORRHAGE FROM FOVEA ALTHOUGH THE LASER WAS FOCUSSED ANTERIOR TO FOVEA. THE USER IMMEDIATELY STOPPED TREATMENT AND REFERRED PATIENT TO RETINA SPECIALIST. THE VISUAL ACUITY POST EVENT WAS 20/100. THE DEVICE LABELING AND RISK ASSESSMENT WAS REVIEWED AND THE RISK CONTROL MEASURES WERE FOUND TO BE ADEQUATE.

    Description of Event or Problem · 0

    THERE WAS AN INCIDENT REPORTED ON THE ELLEX ULTRA Q REFLEX LASER WHERE THE PATIENT DEVELOPED FULL THICKNESS MACULAR HOLE IN LEFT EYE, IMMEDIATELY AFTER THE THIRD LASER PULSE. THIS REPORT IS MADE BY ELLEX WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OF LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759761 ULTRAQ REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U 09342395000427

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention