BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3190752 · Received June 24, 2013

    Report

    Report Number
    2028159-2013-01126
    Event Type
    Malfunction
    Date Received
    June 24, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND THE REPORTED EVENT COULD NOT BE REPLICATED. HOWEVER, THE COMPANY REPRESENTATIVE FOUND A SYSTEM MESSAGE (SM) -- ABNORMAL SYSTEM SHUTDOWN. THE COMPANY REPRESENTATIVE REPLACED THE HOST MODULE. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A HOST MODULE (HM) WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE DID NOT REVEAL ANY DEFECT OR NON-CONFORMITY. THE RETURNED HM WAS INSTALLED ONTO A CALIBRATED SYSTEM. THE SYSTEM WAS TURNED ON AND ALLOW TO BOOT. THE SYSTEM SUCCESSFULLY BOOTED. A CASSETTE WAS INSERTED ONTO THE SYSTEM, WHICH SUCCESSFULLY PRIMED THE CASSETTE. ADDITIONAL TESTING WAS PERFORMED AND TESTING COULD NOT REPLICATE THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THE SCREEN WENT BLANK AFTER THE SURGEON USED THE FOOTSWITCH COMMAND FOR IRRIGATION, DURING A CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. FOLLOWING A TEN MINUTE DELAY, THE PROCEDURE WAS COMPLETED USING AN ALTERNATE SYSTEM. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285114 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1