BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3894605 · Received February 19, 2014

    Report

    Report Number
    2028159-2014-00114
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    December 31, 2013
    Report Date
    December 31, 2013
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED, BUT HAS NOT YET BEEN EVALUATED. THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND SYSTEM MESSAGE (SM) - [ABNORMAL SYSTEM SHUTDOWN] IN THE EVENT LOG. THE CENTRAL PROCESSING UNIT (CPU) HOST WAS REPLACED. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO ADDITIONAL 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 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 NURSE REPORTED THAT A SYSTEM MESSAGE WAS DISPLAYED AND THEY WERE UNABLE TO REBOOT THE SYSTEM DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. FOLLOWING A SYSTEM EXCHANGE, THE PROCEDURE WAS COMPLETED WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105764 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1