BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2171419 · Received June 30, 2011

    Report

    Report Number
    2028159-2011-00732
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE LASER SYSTEM AND REPLACED THE POWER DRIVER PCB. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 MANAGER REPORTED THAT THE SYSTEM'S LASER STOPPED WORKING DURING A PROCEDURE. THE SYSTEM WAS REBOOTED BUT THE LASER DID NOT WORK. ANOTHER LASER WAS USED FROM A DIFFERENT SYSTEM TO COMPLETE THE CASE WITHOUT HARM TO THE PT. ADDITIONAL 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 CTR CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1