BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3881104 · Received April 9, 2014

    Report

    Report Number
    2028159-2014-00609
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 23, 2014
    Manufacturer
    ALCON -IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K121555
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 INFO BECOMES AVAILABLE. NO ADD'L INFO FROM THE REPORTER IS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING A CATARACT SURGERY WHEN THE VISCOELASTIC WAS BEING ASPIRED THE TUBING OF THE CASSETTE OR THE HANDPIECE CLOGGED. NO PT IMPACT REPORTED. NO ADD'L INFO IS EXPECTED. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS BEING FILED FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214160 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON -IRVINE TECHNOLOGY CTR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNSPECIFIED CASSETTE| HANDPIECE