BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC (IN DUOVISC)

    MDR report key: 1941664 · Received December 10, 2010

    Report

    Report Number
    3002037047-2010-00187
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION 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 WERE NO SIMILAR COMPLAINTS RECEIVED FOR THIS LOT. A RETENTION SAMPLE OF THIS BATCH WAS TESTED AND NO PARTICLES WERE SEEN. THE RESULTS OF CLEAR, COLORLESS, SLIGHT SILICONE PRESENT, WERE WITHIN SPECS FOR THE TESTED PARAMETERS. FURTHER COMMENTS WILL BE AVAILABLE AFTER EVAL OF THE COMPLAINT SAMPLE. (B)(4).

    Description of Event or Problem · 1

    A PHARMACIST REPORTED THAT A VISIBLE PARTICLE WAS FOUND INSIDE THE SYRINGE, BEFORE THE SURGERY. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC (IN DUOVISC) AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA 10G02L

    Patients

    Seq Age Sex Outcome Treatment
    1