BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC (IN DUOVISC)

    MDR report key: 3063192 · Received April 11, 2013

    Report

    Report Number
    3002037047-2013-00020
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ALCON - GELGIUM/ S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A MATERIALS SPECIALISTS REPORTED THAT DEBRIS WAS NOTED INSIDE OF THE PRODUCT FLUID, UNDER THE MICROSCOPE, BEFORE IT MADE CONTACT WITH THE PT. A REPLACEMENT PRODUCT WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156368 PROVISC (IN DUOVISC) AID, SURGICAL, VISCOELASTIC LZP ALCON - GELGIUM/ S.A. ALCON-COUVREUR N.V. NA 12I24F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA