BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3772269 · Received December 19, 2013

    Report

    Report Number
    2028159-2013-02380
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    December 4, 2013
    Report Date
    December 4, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    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. A SAMPLE IS EXPECTED, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THERE WAS NO IRRIGATION AND A SYSTEM MESSAGE DISPLAYED DURING QUADRANT REMOVAL OF CATARACT WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE PRODUCT WAS EXCHANGED PROCEDURE COMPLETED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667726 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACTIVE CENTURION FLUID MANAGEMENT SYSTEM PACK