BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3202003 · Received June 27, 2013

    Report

    Report Number
    2028159-2013-01267
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    January 1, 2013
    Report Date
    June 3, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED EVENT. THE COMPANY REPRESENTATIVE CHECKED ALL SYSTEM SPECIFICATIONS AND DOCTOR MEMORY SETTINGS AND FOUND NO NONCONFORMITIES. THE CUSTOMER STATED THAT NORMAL PHACO POWER RETURNED UPON SYSTEM REBOOT. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 (B)(4) 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

    A CUSTOMER REPORTED THAT THE TORSIONAL POWER WAS UNABLE TO BE INCREASED ANY HIGHER THAN 40 PERCENT. THE SYSTEM WAS REBOOTED AND THE POWER WAS THEN ABLE TO BE INCREASED. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293017 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1