BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1823688 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01604
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND REPLACED THE SUPERVISOR MODULE. 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

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCE OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE SURGEON REPORTED A SYSTEM MESSAGE DISPLAYED DURING SURGERY. THE CASSETTE WAS SWITCHED OUT AND THE SYSTEM WAS REBOOTED TO CLEAR THE SYSTEM MESSAGE. THERE WAS A TEN MINUTE DELAY. NO PT INJURY WAS 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 UNK