BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891099 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02039
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 23, 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
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND VERIFIED THE EVENT LOG. THE REP COMPLETED TEMPERATURE OPTIMIZATION. THE SERVICE REP ALSO OBSERVED COMMUNICATION ISSUES BETWEEN THE HOST AND THE LASER MODULE. THE LASER CONTROLLER PCB WAS REPLACED. LASER SYSTEM CALIBRATION WAS COMPLETED AND PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE REPLACED LASER CONTROLLER PCB HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. 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 NURSE REPORTED, THE LASER SHUT DOWN DURING A CASE. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT INJURY REPORTED.

    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