BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS PREMIUM VACUUM PHACO PACK 6/B

    MDR report key: 4927897 · Received July 17, 2015

    Report

    Report Number
    1920664-2015-00116
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE OPENED BL5112 PACK FROM LOT V4123 WAS RETURNED. THE ASSEMBLY WAS DIRTY WITH FLUID IN THE LINES AND WHAT LOOKS LIKE ORGANIC DEBRIS INSIDE THE IN-LINE FILTER. THE ASSEMBLY LOOKS USED. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CASSETTE WAS CAPTURED AND RECOGNIZED BY THE SYSTEM. THE ASSEMBLY PASSED THE SELF VACUUM TEST, PRIMED, IRRIGATED AND ASPIRATED AS INTENDED. THE ASSEMBLY WAS NOT CLOGGED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 2 SEE 1920664-2015-00117.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE TUBING BECAME CLOGGED AND THEY WERE UNABLE TO PROCEED. THEY OPENED A NEW PACK RESET THE SYSTEM, AND COMPLETED THE SURGERY. NO MEDICAL INTERVENTION WAS NEEDED, AND THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465232 STELLARIS PREMIUM VACUUM PHACO PACK 6/B PREMIUM VACUUM PHACO PACK 6/B HQC BAUSCH & LOMB, INC. V4123

    Patients

    Seq Age Sex Outcome Treatment
    1