BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3853110 · Received April 2, 2014

    Report

    Report Number
    2028159-2014-00557
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 6, 2014
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE THE FOOTSWITCH PRESENTED A PROBLEM. THE SURGERY WAS COMPLETED USING AN ALTERNATE SYSTEM WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199884 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1