BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3983283 · Received July 2, 2014

    Report

    Report Number
    2028159-2014-01253
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ALCON MANUFACTURING, LTD.
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 2 CFR 803.56 WHEN ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DID NOT RECOGNIZE THE FOOTSWITCH AND LOCKED PRIOR TO A CATARACT PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE CASE WAS COMPLETED WITH AN ALTERNATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387083 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON MANUFACTURING, LTD. INFINITI OZIL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA