BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1992853 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00075
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Report Date
    January 7, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: THE COMPANY REP CONFIRMED THAT THE REPORTED SYSTEM MESSAGE WAS OCCURRING. THE FOOTSWITCH CABLE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. ROOT CAUSE: A ROOT CAUSE HAS NOT BEEN IDENTIFIED. THE ROOT CAUSE WILL BE REASSESSED UPON COMPLETING THE INVESTIGATION. ACTIONS TAKEN: NO ACTION IS PLANNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: THE FOOTSWITCH WAS NOT RECOGNIZED BY THE SYSTEM. NO PT IMPACT WAS REPORTED. ADDITIONAL INFO WAS 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