BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3813286 · Received March 28, 2014

    Report

    Report Number
    2028159-2014-00542
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    January 1, 2014
    Report Date
    March 3, 2014
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REPRESENTATIVE DISCUSSED THE SETUP WITH THE DOCTOR AND STAFF. THE DOCTOR STATED THAT THE TIP SELECTED MAY HAVE CAUSED THE LOST PHACO POWER. THE OPERATOR'S MANUAL, STATES THAT "DIFFERENT HANDPIECE, TIPS, AND INFUSION SLEEVES ARE REQUIRED FOR DIFFERENT PROCEDURAL STEPS AND/OR FUNCTIONS." THEREFORE, A TIP THAT IS NOT COMPATIBLE WITH THE HANDPIECE WILL CAUSE THE HANDPIECE TO NOT FUNCTION AS INTENDED WITH THE SET SYSTEM PARAMETERS. AFTER REVIEWING THE COMPLAINT, IT IS DETERMINED THAT THE SYSTEM WAS FUNCTIONING AS INTENDED. THE CUSTOMER WAS ABLE TO TROUBLESHOOT AND RESOLVED THE PROBLEM REPORTED. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS 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

    THE CUSTOMER REPORTS DURING A PROCEDURE THEY LOST PHACO POWER. THE PROCEDURE WAS COMPLETED FOLLOWING A SYSTEM EXCHANGE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184539 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1