BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS PC VISION ENHANCEMENT SYSTEM

    MDR report key: 5233550 · Received November 18, 2015

    Report

    Report Number
    0001920664-2015-00207
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 26, 2015
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. ONE OPENED 23GA VIT CUTTERS WAS RETURNED IN A PLASTIC ZIP LOCK BAG WITH A BL5623 POUCH FROM LOT V5101. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION IN THE ASPIRATION LINE. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE INNER NEEDLE DOES NOT RETRACT FROM THE PORT WINDOW, CAUSING IT TO BE BLOCK. THE CUTTER CANNOT CUT OR ASPIRATE. REPORT 1 OF 5 SEE 1920664-2015-00208, 00209, 00210, 00211.

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 5, SEE 1920664-2015-00208,00209,00210, AND 00211.

    Description of Event or Problem · 1

    THE USER FACILITY IN KOREA REPORTED. THE VITRECTOMY CUTTER'S FUNCTION WASN'T WORKING PROPERLY. THERE WAS NO PATIENT IMPACT OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764068 STELLARIS PC VISION ENHANCEMENT SYSTEM UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5623 V5101

    Patients

    Seq Age Sex Outcome Treatment
    1