BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 4181111 · Received October 14, 2014

    Report

    Report Number
    2028159-2014-01887
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 15, 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
    MA, 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. THERE HAVE BEEN NO ADDITIONAL COMPLAINTS REPORTED AGAINST THE FINISHED GOODS LOT AND THE DEVICE HISTORY RECORD SHOWS THAT THE PRODUCT WAS RELEASED PER SPECIFICATIONS. THE CUSTOMER DID NOT RETAIN A SAMPLE FOR THIS COMPLAINT REPORT; VISUAL INSPECTION OR FUNCTIONAL TESTING COULD NOT BE CONDUCTED. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT KINKED TUBING WAS NOTICED DURING PRIMING FOR A CATARACT PROCEDURE. TO RESOLVE THE ISSUE THE STAFF OPENED THREE PACKS. THEY FOUND THAT THESE THREE PACKS CONTAINED KINKED TUBING AS WELL. THE ISSUE WAS FINALLY RESOLVED BY TAPING THE TUBING TO THE MACHINE. AFTER FLUID BEGAN TO FLOW FROM THE CONSOLE THROUGH THE TUBING, THE NURSE REPORTED THAT THE KINK DISAPPEARED. THERE WAS NOT ANY REPORT OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649995 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INTREPID PLUS BASIC PACK