BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1940093 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02421
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE REPORTED. THE FLUIDICS MODULE WAS REPLACED. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A SYSTEM MESSAGE WAS RECEIVED IN THE MIDDLE OF A SURGICAL PROCEDURE. A LEAKY CASSETTE WAS ALSO REPORTED. THE SYSTEM WAS UNABLE TO BE USED TO COMPLETE THE PROCEDURE. NO ADD'L DETAILS WERE GIVEN. THE SURGEON IS NOT WILLING TO PROVIDE AN FURTHER DETAILS ABOUT THE EVENT.

    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