BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1894931 · Received November 5, 2010

    Report

    Report Number
    2028159-2010-02153
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE IRRIGATION FUNCTION WAS TESTED AND ALL OTHER FUNCTIONS AND OPERATIONS WERE TESTED FOR PROPER OPERATION. THE SYSTEM MET ALL PROD SPECS. A COMPANY SALES REP WAS CONTACTED TO HELP DETERMINE WHY THE DR IS HAVING PROBLEMS WITH THE IRRIGATION. THE SALES REP VISITED THE FACILITY AND CHANGED THE BOTTLE HEIGHT SETTING. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THE SURGICAL PARAMETERS WERE CHANGED BEFORE A CASE. DURING THE CASE, THE CHAMBER WAS COLLAPSING. THE BOTTLE HEIGHT AND SURGICAL PARAMETERS WERE CHANGED AGAIN AND THE CASE WAS COMPLETED WITHOUT INJURY. PRIOR TO BEGINNING THE NEXT CASE, THE SYSTEM WAS SWITCHED OUT.

    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 Required Intervention