BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTURION VISION SYSTEM

    MDR report key: 3851740 · Received April 22, 2014

    Report

    Report Number
    2028159-2014-00730
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    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
    IN
    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 BLOCKAGE IN THE TUBING DURING THE IRRIGATION AND ASPIRATION (I/A) PORTION OF A CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANT PROCEDURE. THE SURGEON CLARIFIED THAT THERE WAS NOT ENOUGH SUCTION TO REMOVE THE VISCOELASTIC WHICH RESULTED IN THE BLOCKAGE. THE SURGERY WAS COMPLETED BY USING A BIMANUAL I/A TIP TO REMOVE THE VISCOELASTIC. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243683 CENTURION VISION SYSTEM PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PHACO TIP| HANDPIECE| COHEVISC (SODIUM HYLONUNATE)| CENTURION FMS PAK