BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 2211672 · Received August 5, 2011

    Report

    Report Number
    1920664-2011-00101
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THE PRODUCT HAS BEEN REQUESTED FOR EVALUATION; HOWEVER; IT IS UNK IF IT WILL BE RETURNED. REPORT 2 OF 2.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATES: "VITRECTOMY CUTTERS FAIL IN CUTTING VITREOUS DURING RETINAL PROCEDURES. SOME CUTTERS FAIL FROM THE START WHILE OTHERS INITIALLY WORK AND THEN FAIL AFTER A WHILE. NO ISSUES WITH PTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQC BAUSCH & LOMB U4899

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS EQUIPMENT (BAUSCH & LOMB)