BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2180945 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00760
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 7, 2011
    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
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE HOST MODULE AND THE POWER CONTROLLER PRINTED CIRCUIT BOARD (PCB). THE SYSTEM WAS THEN TESTED AND MET SPECS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE UNIT TURNED OFF UNEXPECTEDLY DURING A PROCEDURE. THE CASE WAS COMPLETED AFTER THE FACILITY PLUGGED THE UNIT INTO A DIFFERENT POWER OUTLET. THERE WAS NO PT HARM REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    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