BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 3190742 · Received June 24, 2013

    Report

    Report Number
    2028159-2013-01164
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROGRESS. A SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT WATER LEAKED FROM THE TUBE OF THE CASSETTE DURING PRIMING TEST. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286393 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 MAXVAC BASIC PAK| CUSTOM PAK