BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2171429 · Received June 30, 2011

    Report

    Report Number
    2028159-2011-00737
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM, CLEANED THE FLUIDICS MODULE, AND REPLACED THE CASSETTE TYPE PRINTED CIRCUIT BOARD (PCB) AND VENT STINGER. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE CASSETTE TYPE PCB IS RETURNING FOR IN-HOUSE EVAL. 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

    AN ENGINEER REPORTED A SYSTEM MESSAGE WAS DISPLAYED INDICATING A CASSETTE NEEDED TO BE INSERTED EVEN AFTER THE CASSETTE WAS IN THE MACHINE. THE PROCEDURE WAS CANCELED AFTER THE PT HAD RECEIVED A LOCAL ANESTHETIC. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1