BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 4213049 · Received October 24, 2014

    Report

    Report Number
    1644019-2014-00180
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 A CORNEAL OPACITY WAS CONFIRMED AFTER THE CATARACT PROCEDURE HAD BEEN PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS REPORT. REPORT INFORMATION RECEIVED INDICATED THAT THERE IS NO PRODUCT SAMPLE AVAILABLE FOR EVALUATION FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678601 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA 1633996H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 30 DEGRE BALANCE TIP| CENTURION FLUIDICS MANAGEMENT SYSTEM