BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2092836 · Received May 5, 2011

    Report

    Report Number
    2028159-2011-00497
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RETURNED AND IN-HOUSE TESTING IS IN PROGRESS. THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF 04/12/2010 THROUGH 04/12/2011; THIS IS ONE OF 6 COMPLAINT REPORTS RELATING TO 3426 SMC AND BLOCKAGE. THE DHR AND LOT COMPLAINT HISTORY COULD NOT BE REVIEWED AS THE CUSTOMER DID NOT KNOW THE LOT NUMBER. 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 DURING A PROCEDURE, A SYSTEM MESSAGE WAS DISPLAYED AND THEN THE SYSTEM LOCKED. ADDITIONAL INFO WAS RECEIVED FROM THE SVC TECH REPORTING AFTER RECEIVING THE SYSTEM MESSAGE, THE SYSTEM WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED. THE BACK OF THE CASSETTE WAS REPORTED TO HAVE BEEN WET. THERE WAS NO PT IMPACT REPORTED. THIS IS THE FIRST OF THREE REPORTS BEING FILED FOR THIS FACILITY.

    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