BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1891090 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02047
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 23, 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
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM. THE FLUIDICS MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED, AT THE END OF THE PROCEDURE, THE SYSTEM DISPLAYED AN ERROR MESSAGE WHICH DEACTIVATED FUNCTIONS. THE PT WAS UNDER ANESTHESIA AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED BUT THE FOLLOWING TWO PROCEDURES WERE CANCELED. THERE WAS NO PT HARM 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