BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS OPTIMIZED STABILITY VACUUM PACK

    MDR report key: 2211671 · Received August 5, 2011

    Report

    Report Number
    1920664-2011-00093
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 7, 2011
    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 STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND. THE PRODUCT HAS BEEN RECEIVED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATES: "TROCAR CAN NOT PIERCE THE EYE, SLEEVE RETRACTS AND CAN NOT FIND THE SCLERA. NO PT IMPACT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARIS OPTIMIZED STABILITY VACUUM PACK HQC BAUSCH & LOMB U5258

    Patients

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