BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4121442 · Received July 29, 2014

    Report

    Report Number
    2028159-2014-01387
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REPRESENTATIVE ADVISED TO TRY A DIFFERENT HANDPIECE. NO ADDITIONAL INFO WAS PROVIDED AND THE SERVICE RECORD (SR) WAS CLOSED. THE SAMPLE WAS NOT OBTAINED FOR EVAL. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO DETERMINE ROOT CAUSE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 1 RELATED REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED LOW VACUUM DURING PHACOEMULSIFICATION MODE OF A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE SURGERY WAS COMPLETED USING THE SAME SYSTEM WITH NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442821 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1