BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2801131 · Received October 17, 2012

    Report

    Report Number
    2028159-2012-01626
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM. THE COMPANY REP RELOADED THE SYSTEM SOFTWARE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. NO SAMPLES WERE RETURNED FOR EVAL AND NO ADD'L INFO 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 INDICATE ONE SIMILAR REPORT FOR THE SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    AN OPERATING ROOM MANAGER REPORTED THAT AS THE TECH WAS CHANGING THE TIP ON THE HANDPIECE, THE SYSTEM SHUT DOWN ON ITS OWN THEN TURNED BACK ON AND REBOOTED DURING A PROCEDURE. AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PT.

    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