BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 10099860 · Received May 29, 2020

    Report

    Report Number
    3002806902-2020-00004
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    December 15, 2019
    Report Date
    May 29, 2020
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    UDI-DI
    09342395000427
    PMA / PMN Number
    K021550
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAS BEEN IN USE SINCE JUL'2017 , AND IS BEING USED TILL DATE , THERE WERE NO OTHER ADVERSE EVENTS REPORTED FOR THE SYSTEM. THE CAUSE CAN BE ATTRIBUTED TO THE USER CONTINUING THE LASER TREATMENT DESPITE THE COAXIAL ILLUMINATION NOT WORKING RESULTING IN INACCURATE TARGETING ON THE NATURAL LENS ,LEADING TO TRAUMATIC CATARACT. THE DEVICE LABELING AND RISK CONTROL MEASURES WERE VERIFIED AND WERE DEEMED ADEQUATE.

    Description of Event or Problem · 1

    ELLEX SERVICES EUROPE RECEIVED A COMPLAINT FROM THE USER FACILITY THAT THE SURGEON PERFORMED A FLOATER TREATMENT ON A PHAKIC PATIENT WITHOUT COAXIAL ILLUMINATION, WHICH LED HIM TO SHOOT THE CRYSTALLINE LENS CAUSING AN IMMEDIATE TRAUMATIC CATARACT. THE EVENT OCCURRED IN (B)(6) 2019 HOWEVER WAS COMMUNICATED TO THE ELLEX SERVICE TECH DURING THE SUBSEQUENT SERVICE CALL ON 4THMAY'2020. THE PATIENT HAD BEEN ADVISED FOR CATARACT SURGERY. 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
    564140 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U 09342395000427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention