BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS PREMIUM VACUUM PHACO PACK 6/B

    MDR report key: 4927918 · Received July 17, 2015

    Report

    Report Number
    1920664-2015-00113
    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

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 3 OF 5 SEE 1920664-2015-00111,00112,00114,00115.

    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
    465072 STELLARIS PREMIUM VACUUM PHACO PACK 6/B PREMIUM VACUUM PHACO PACK 6/B HQC BAUSCH & LOMB, INC. V4890

    Patients

    Seq Age Sex Outcome Treatment
    1