BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1891064 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02104
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 29, 2010
    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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ABLE TO DIAGNOSE THE ISSUE AND FOUND THE ISSUE WAS WITH THE CABLE AND NOT THE FOOTSWITCH. THE FACILITY HAS ORDERED A NEW FOOTSWITCH CABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS RECEIVED DURING A CASE. THE CABLE WAS RESEATED AT EACH END BUT STILL DID NOT RESOLVE THE ISSUE. THE FOOTSWITCH WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS A SLIGHT DELAY EXPERIENCED, BUT NO PATIENT HARM OR CANCELLATIONS. AT THE END OF THE DAY, THE CUSTOMER WAS ABLE TO DIAGNOSE THE SYSTEM AND THE ISSUE WAS WITH THE CABLE, NOT THE FOOTSWITCH.

    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