BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 2802998 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01606
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 20, 2012
    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
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND NOTED SYSTEM MESSAGE (SM) [FOOTSWITCH - DETENT FAILURE]. THE COMPANY REPRESENTATIVE REPLACED THE FOOTSWITCH AND THE FOOTSWITCH CABLE. THE SYSTEM WAS THEN TESTED AND MET 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 24 MONTHS DID NOT INDICATE ANY ADDITIONAL RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED A SYSTEM MESSAGE AND HAD PROBLEMS WITH THE FOOTSWITCH DURING A CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. FOLLOWING A DELAY OF 30 MINUTES, THE CASE WAS ABLE TO BE COMPLETED WITH THE SAME EQUIPMENT. THERE WAS NO HARM TO THE PATIENT.

    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