BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2960485 · Received January 25, 2013

    Report

    Report Number
    2028159-2013-00003
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE A SYSTEM MESSAGE DISPLAYED THAT COULD NOT BE CLEARED. AN ALTERNATE SYSTEM WAS BROUGHT IN AND USED, BUT ALSO PRESENTED PROBLEMS. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35426 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 LEGACY SYSTEM