BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 3770994 · Received December 18, 2013

    Report

    Report Number
    2028159-2013-02398
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 21, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A CATARACT SURGERY THE SYSTEM STOPPED WITHOUT ANY ERROR MESSAGE AND COULD NOT BE RESTARTED. THE EVENT OCCURRED AT THE "RIFTING PHASE" OF THE SURGERY. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, WHERE THE SURGERY WAS COMPLETED WITH NO CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664190 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention