BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1791484 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01427
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ALCON - IRVIE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND THE SYSTEM PASSED ALL FUNCTIONAL TESTS. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE CUSTOMER WILL SEND THE CASSETTE AND LASER PROBE FOR IN-HOUSE EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT HARM/INJURY" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "INFUSION ISSUES" (INFUSION OR FLOW ISSUE). THE SURGEON REPORTED THERE WERE PROBLEMS WITH THE INFUSION MODULE OF THE SYSTEM. THE SURGERIES WERE COMPLETED WITH NO HARM TO THE PTS. THE NUMBER OF SURGERIES AND PTS AFFECTED WAS UNK. THE SURGEON FURTHER REPORTED HE HAD PROBLEMS WITH THE RECOGNITION OF THE SYSTEM CASSETTE AND THE LASER PROBE. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK