BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2172650 · Received June 24, 2011

    Report

    Report Number
    2028159-2011-00749
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYS. THE COMPANY REP EXAMINED THE SYS AND CONFIRMED A FRONT PANEL COMMUNICATION NON-CONFORMITY AND A RED SCREEN. IT IS UNCLEAR WHETHER THE REPORTED EVENT "INTERMITTENT SHUTDOWN" WAS REPLICATED DURING ON-SITE SYS VERIFICATION. THE BOARDS AND CONNECTIONS WERE CLEANED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECS. NO SAMPLES WERE RETURNED FOR EVAL. THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING THE IRRIGATION AND ASPIRATION PORTION OF CATARACT SURGERY, THE SYS SHUT ITSELF OFF. THE SYS WAS REBOOTED BUT THE SHUTDOWN OCCURRED AGAIN, INTERMITTENTLY. THE SURGEON CONCLUDED THE SURGERY BY SWITCHING TO A MANUAL TECHNIQUE. THERE WAS NO HARM TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1