BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 2960464 · Received January 25, 2013

    Report

    Report Number
    3002037047-2013-00006
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 27, 2012
    Manufacturer
    ALCON - BELGIUM/ 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: 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. NO REMARKS IN BATCH RECORD FILLING REGARDING THE PRESENCE OF FIBERS. THE REFERENCE SAMPLES WERE INSPECTED, NO FOREIGN MATERIAL WAS OBSERVED. THERE HAVE BEEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED NOTHING FOREIGN MATERIAL LIKE FIBER WAS FOUND IN THE SYRINGE BEFORE USAGE OF THIS PRODUCT. THERE WAS NO PATIENT INVOLVED. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35467 PROVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V. NA 12H06F

    Patients

    Seq Age Sex Outcome Treatment
    1