BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3904773 · Received May 28, 2014

    Report

    Report Number
    2028159-2014-01011
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 1, 2014
    Manufacturer
    ALCON - IRVINE TECH CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITION REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED EXPERIENCING NO ASPIRATION ON CORTEX SETTING, THE SYSTEM FROZE AND HAD TO RESET IT DURING A CATARACT PROCEDURE. IN THE ASPIRATION MODE THERE WERE NO FLUID INFUSING IN THE EYE AND THE ANTERIOR CHAMBER COLLAPSED. THE PROCEDURE WAS COMPLETED BY RESETTING THE PARAMETERS. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314902 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECH CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK