BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO INCISION VACUUM PHACO PACK

    MDR report key: 4060365 · Received August 8, 2014

    Report

    Report Number
    1920664-2014-00145
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 15, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY HAS DISCARDED THE PRODUCT, IT IS NOT AVAILABLE FOR EVAL. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN FRANCE STATING: "BAD QUALITY OF THE SLEEVE. DOES NOT ENTER BY 1.8 MM INCISION. NO PT IMPACT. NO PRODUCT RETURNED, THEY CHANGED THE SLEEVE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473123 MICRO INCISION VACUUM PHACO PACK STELLARIS ANTERIOR SYSTEM HQC BAUSCH & LOMB BL5113 V2566

    Patients

    Seq Age Sex Outcome Treatment
    1