BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3190658 · Received June 21, 2013

    Report

    Report Number
    2028159-2013-01236
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 23, 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
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE CUSTOMER STATED THAT THE REPORTED EVENT WAS A RESULT OF ERROR. THE CUSTOMER STATED THAT THE SYSTEM TESTED FINE PRIOR TO SURGERY AND THE EVENT OCCURRED WHEN CHANGING SETTINGS. THE COMPANY REPRESENTATIVE PERFORMED AN IN-SERVICE WITH THE NURSES REVIEWING THE TOUCHSCREEN FUNCTIONALITY WHILE IN PHACO MODE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE FOR THIS REPORTED EVENT CAN BE ATTRIBUTED TO USER ERROR. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SYSTEM HAD NO POWER WHEN CHANGING MODES FROM PHACO POWER 2 TO PHACO POWER 3 DURING A CATARACT EXTRACTION PROCEDURE. AN ALTERNATE SYSTEM, COMBINED WITH THE SAME HANDPIECE, WAS USED TO COMPLETE THE PROCEDURE WITH NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER INDICATING THAT THE REPORTED EVENT WAS THE RESULT OF A USER ERROR AND THAT THE STAFF HAS PARTICIPATED IN AN INSERVICE TO LEARN ABOUT SETTINGS TO PREVENT FUTURE INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282850 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON-IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1