BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3912465 · Received May 14, 2014

    Report

    Report Number
    2028159-2014-00911
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 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
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS IN PROCESS. THE DEVICE WAS RECEIVED BY A COMPANY REPRESENTATIVE AND IS IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING CATARACT SURGERY THE FLUID PRESSURE WAS LOW. THE CASSETTE WAS REMOVED AND REPLACED WITH A NEW CASSETTE TO CONTINUE THE SURGERY. THE PROCEDURE WAS COMPLETED, WITHOUT HARM OR IMPACT TO THE PT. THERE IS NO ADDITIONAL INFO EXPECTED TO BE OBTAINED FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288137 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