BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 1940837 · Received December 17, 2010

    Report

    Report Number
    2028159-2010-02405
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 18, 2010
    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

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED LEAKAGE DURING A PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT IMPACT AND DETAILS OF THE REPORTED EVENT.

    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