BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2092833 · Received May 5, 2011

    Report

    Report Number
    2028159-2011-00488
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES ARE RETURNING FOR EVAL. THE ROOT CAUSE HAS NOT BEEN DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS MGR REPORTED RECEIVING INTERMITTENT PHACO AND IRRIGATION/ASPIRATION POWER DURING A PROCEDURE EVEN WHEN THE PEDAL WAS ALL THE WAY DOWN. ADDITIONAL INFO WAS RECEIVED FROM THE OPERATING ROOM CIRCULATOR INDICATING THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO DELAY. THERE WAS NO PT HARM 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