BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1891095 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02042
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 23, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP EXAMINED THE SYSTEM. THE FOOTSWITCH WAS CLEANED AND LUBRICATED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THERE WAS NO IRRIGATION WHEN THE FOOTSWITCH WAS ACTIVATED. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1