BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891077 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02027
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AFTER CONNECTING THE CASSETTE, A SYSTEM MESSAGE WAS DISPLAYED. THE SYSTEM WAS THEN REBOOTED. AFTER THE PRIMING SEQUENCE WAS COMPLETED, ANOTHER SYSTEM MESSAGE WAS DISPLAYED. DURING I/A, THE IRRIGATION MODULE SHUT DOWN AFTER A SYSTEM MESSAGE WAS DISPLAYED. THE SYSTEM WAS REBOOTED ONCE MORE AND AFTER ABOUT 10 MIN DELAY THE SURGEON WAS ABLE TO COMPLETE THE SURGERY. AFTER THE CASE WAS COMPLETED, THE STAFF NOTICED AN OILY FLUID UNDERNEATH THE MACHINE WITH A VINEGAR LIKE SMELL. THE FOLLOWING CASE WAS CANCELED. MULTIPLE ATTEMPTS WERE MADE TO ACQUIRE ADD'L INFO BUT NONE HAS BEEN REC'D TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1