BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2081353 · Received April 22, 2011

    Report

    Report Number
    2028159-2011-00421
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED AND TESTED THE SYSTEM AND NOTICED THE DIGITAL VIDEO INTERFACE (DVI) RECEIVER PCB HAD A DAMAGED COMPONENT. THE COMPANY REP REPLACED THE DVI RECEIVER PCB, THE 12V POWER SUPPLY, THE HOST CPU, AND THE DISPLAY SUB-ARM. PREVENTIVE MAINTENANCE WAS PERFORMED AND SOFTWARE UPDATE WAS COMPLETED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ADDITIONAL INFO REGARDING PRODUCT EVAL IS PENDING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TOUCH SCREEN RESPONSE PROBLEMS AND AN ELECTRICAL SMELL FROM THE UNIT WAS NOTICED. ADDITIONAL INFO WAS REQUESTED. ADDITIONAL INFO WAS RECEIVED FROM A NURSE REPORTING THE SURGEON HAD REMOVED THE CATARACT, FINISHED IRRIGATION/ASPIRATION, AND WHEN HE SWITCHED TO THE "VISCO" SETTING TO REMOVE THE VISCOELASTIC, THE TOUCH SCREEN STOPPED RESPONDING. AT THAT TIME, AN ELECTRICAL SMELL COMING FROM THE SYSTEM WAS NOTICED. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED. THERE WAS NO PT HARM 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