BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3963328 · Received May 21, 2014

    Report

    Report Number
    2028159-2014-00944
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT HISTORY WAS REVIEWED FOR THE PERIOD OF ONE YEAR; THIS IS THE FIRST COMPLAINT REPORTED FOR THIS ISSUE. AS THE CUSTOMER DID NOT RETAIN THE FINISHED GOODS LOT NUMBER, DEVICE HISTORY RECORD (DHR) AND LOT HISTORY COULD NOT BE REVIEWED. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE IS UNKNOWN. A SAMPLE WAS NOT RETURNED FOR THIS COMPLAINT WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO ISOLATE THE ROOT CAUSE. (B)(4).

    Description of Event or Problem · 1

    A NURSE SUPERVISOR REPORTED AN OCCLUSION DURING A VITRECTOMY PROCEDURE. THE OCCLUSION WAS BELIEVED TO HAVE BEEN IN THE TUBING. THE SYSTEM WAS EXCHANGED TO COMPLETE THE PROCEDURE WITHOUT TROUBLESHOOTING THE PROBLEM. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301525 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 CUSTOM PAK