BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA Q REFLEX

    MDR report key: 6146668 · Received December 5, 2016

    Report

    Report Number
    9680659-2016-00004
    Event Type
    Injury
    Date Received
    December 5, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ELLEX MEDICAL PTY LTD
    Product Code
    HQF
    PMA / PMN Number
    K992824
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS SOON AS ELLEX MEDICAL BECAME AWARE OF THE INCIDENT, THE COMPLAINT WAS RECORDED , DEVICE CONTAINED . THE CALIBRATION OF THE LASER SYSTEM AND ALIGNMENT OF THE OPTICAL PATHS WAS VERIFIED BY ELLEX SERVICE THROUGH A PAF (PRODUCT ACCEPTANCE FAULT RECORD) POST EVENT. ALL THE PARAMETERS IN ALIGNMENTS CHECKS INCLUDING OFFSET IN THE PAF WERE RECORDED ARE WITHIN THE ACCEPTANCE CRITERIA (POSTERIOR OFFSET - 200UM POSTERIOR FROM THE NORMAL POSITION) WHICH PROVES THAT THE CONSERVATIVE ALIGNMENT (MINOR MIS-ALIGNMENT )OF THE POSTERIOR OFFSET SHOULD IN FACT MAKE THE LASER LESS LIKELY TO CAUSE ANY DAMAGE TO THE PATIENT LENS. IT CAN BE DEDUCED THAT THE LASER DEVICE (UR0715) DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE PREVIOUS RECORD DURING INSTALLATION / DURING PRODUCTION (COMMISSIONING BOOK) WAS ALSO FOUND TO BE COMPLIANT. THE GENERAL DEVICE ASPECTS WITH RESPECT TO USABILITY, INSTRUCTIONS FOR USE AND THE RISK CONTROLS WERE ALSO EVALUATED. ADEQUACY OF LABELLING : OPERATOR MANUAL INCLUDES SUFFICIENT INSTRUCTIONS , WARNINGS , PRECAUTIONS FOR THE SAFE USE OF THE DEVICE AND THE LABELLING IS CONSIDERED ADEQUATE. DO NOT AIM, FOCUS OR FIRE THIS DEVICE IN, ON OR NEAR THE FOVEA; ON CORNEAL STRUCTURES; ON THE PATIENT'S LENS (NATURAL OR ARTIFICIAL); OR ON ANY OTHER STRUCTURE OF THE HUMAN BODY THAT IS NOT RELATED TO THE TREATMENT OF AN EYE DISORDER. SET THE POSTERIOR (P) OFFSET TO AT LEAST 100MICROM WITH A MINIMUM ENERGY SETTING. IF USING A HIGHER ENERGY SETTING CHOOSE A GREATER POSTERIOR (P) OFFSET. ONLY FULLY TRAINED AND QUALIFIED PHYSICIANS MAY OPERATE THIS DEVICE. THIS DEVICE IS A SAFE INSTRUMENT WHEN USED CORRECTLY. HOWEVER, LIKE ALL LASER SURGICAL EQUIPMENT, IT CAN CAUSE INJURY IF NOT USED IN ACCORDANCE WITH THE CORRECT SAFETY PROCEDURES AND OPERATING INSTRUCTIONS. RISK MANAGEMENT : REVIEW INDICATED THAT THE RISK CONTROL MEASURES (RISK ASSESSMENT) ARE ADEQUATE AND WITHIN THE NORMAL USE RISK LEVELS ARE ACCEPTABLE. CUSTOMER COMPLAINTS : THE DEVICE IS NEW AND THE INSTALLATION PAF DOES NOT INCLUDE ANY ERRORS.

    Description of Event or Problem · 1

    POSTERIOR MEMBRANECTOMY (VITREOLYSIS OF FLOATER) PERFORMED WITH LASER. LASER APPLIED TO FLOATER TWICE AT 2MJ SETTING , 300-400 MICRONS POSTERIOR OFFSET. SECOND LASER PULSE CAUSED THE VISIBLE DEFECT IN THE POSTERIOR CAPSULE. HIT THE NATURAL LENS, CATARACT DEVELOPED, IMMEDIATELY TERMINATED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795981 ULTRA Q REFLEX OPHTHALMIC LASER HQF ELLEX MEDICAL PTY LTD LQP3106-U

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability