BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2193006 · Received July 21, 2011

    Report

    Report Number
    2028159-2011-00815
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) TO ASSIST WITH TROUBLESHOOTING. THE TSS ADVISED THE CUSTOMER TO ORDER A NEW FOOTSWITCH AND CABLE. THE CUSTOMER DID NOT CALL BACK TO ORDER THE PRODUCTS. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SYSTEM MESSAGE RELATED TO THE FOOTSWITCH DISPLAYED DURING A PROCEDURE. THE CASE WAS STOPPED AND THE PT WAS MOVED INTO THE RECOVERY AREA UNTIL AN ALTERNATE FOOTSWITCH WAS DELIVERED. THE CASE WAS COMPLETED USING THE ALTERNATE FOOTSWITCH ON THE SAME DAY FOLLOWING A SIX HOUR DELAY. THERE WAS NO PT HARM. ADDITIONAL 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