BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI OZIL

    MDR report key: 1586380 · Received January 14, 2010

    Report

    Report Number
    1586380
    Event Type
    Malfunction
    Date Received
    January 14, 2010
    Date of Event
    December 21, 2009
    Report Date
    January 14, 2010
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHACO MACHINE SHOWED AN OCCLUSION AND WAS UNABLE TO CLEAR AFTER GOING THROUGH ALL OF THE STEPS AND CHANGING THE ATTACHMENTS. MANUFACTURER RESPONSE (AS PER REPORTER) FOR PHACO EMULSIFIER, INFINITY OZILUNABLE TO DUPLICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI OZIL PHACO EMULSIFIER HQC ALCON LABORATORIES INFINITI OZIL *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NO OTHER THERAPIES