BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1970061 · Received January 14, 2011

    Report

    Report Number
    2028159-2011-00043
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    December 17, 2010
    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
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE VENT AND IRRIGATION SOLENOID SPACERS ON THE FLUIDICS MODULE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING CATARACT SURGERY A SYSTEM MESSAGE WAS DISPLAYED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY EXCHANGING SYSTEMS. THERE WAS NO HARM TO THE PT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK