BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2072387 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00346
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, A SYSTEM MESSAGE WAS DISPLAYED. DESPITE THE SETTING UP OF ANOTHER FOOTSWITCH, THE SYSTEM MESSAGE PERSISTED. INITIALLY, IT WAS REPORTED THAT THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE SURGERY. ADDITIONAL INFO RECEIVED INDICATES THAT THE PT REMAINED AT THE SAME HOSPITAL AND ANOTHER SYSTEM WAS BROUGHT IN TO COMPLETE THE SURGERY. THERE WAS A DELAY IN COMPLETING THE CASE, BUT NO HARM TO THE PT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI