BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITI VISON SYSTEM OZIL

    MDR report key: 3830557 · Received May 5, 2014

    Report

    Report Number
    2028159-2014-00805
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE REPORT HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE SYSTEM EXPERIENCED AN OVERPOWER OF THE ELECTRICAL POWER SUPPLY DURING SURGERY. A SYSTEM MESSAGE WAS DISPLAYED. THE SURGERY COULD NOT BE CONTINUED AT THAT MOMENT BY CLASSICAL/MANUAL PROCEDURE AND THE PATIENT WAS TRANSFERRED URGENTLY TO ANOTHER HOSPITAL FOR SURGERY. THE PATIENT IMPACT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268051 INFINITI VISON SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention