BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2230518 · Received August 12, 2011

    Report

    Report Number
    2028159-2011-00943
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED ALTHOUGH THE PHYSICIAN WAS PRESSING THE FOOTSWITCH, THE SCRUB TECH CHANGED MODES FROM CORTEX TO COAG BY PRESSING THE TOUCHSCREEN BY MISTAKE. THE SURGEON HAS EXPRESSED DISSATISFACTION BECAUSE THE MODE WAS ABLE TO BE SWITCHED WHILE THE FOOTSWITCH WAS ENGAGED. NO SERVICE WAS REQUESTED. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED WHILE PRESSING THE FOOTSWITCH IN CORTEX MODE, THE SETTING WAS ACCIDENTALLY CHANGED TO COAG MODE BY THE SCRUB TECH. AS A RESULT, THE ANTERIOR CHAMBER FLATTENED. THE CUSTOMER TRIED SWITCHING BACK TO CORTEX MODE BUT COULD NOT BECAUSE THE FOOTSWITCH WAS STILL DEPRESSED. ADD'L INFO HAS BEEN REQUESTED.

    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 Required Intervention