BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1791497 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01403
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 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
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE. THE SOFTWARE WAS UPGRADED. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): ¿NO PATIENT INVOLVED¿ (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): ¿SYSTEM MESSAGE DISPLAYED¿ (DEVICE DISPLAYS ERROR MESSAGE). THE SURGEON REPORTED A SYSTEM MESSAGE DISPLAYED DURING SET UP. THE SYSTEM WAS REBOOTED AND THE CASSETTE WAS SWITCHED OUT BUT THE SYSTEM MESSAGE WOULD NOT CLEAR. THE SYSTEM WAS SWITCHED OUT AND THE CASE PROCEEDED. NEITHER CASSETTE NOR THE CASSETTE LOT NUMBER WAS RETAINED. THE PATIENT HAD RECEIVED TOPICAL ANESTHESIA. THE CASE WAS COMPLETED AS PLANNED. NO PATIENT 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