BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC (IN DUOVISC)

    MDR report key: 3880989 · Received April 7, 2014

    Report

    Report Number
    3002037047-2014-00035
    Event Type
    Malfunction
    Date Received
    April 7, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 10, 2014
    Manufacturer
    ALCON - BELGIUM / ALCON N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. 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

    THE NURSE REPORTED THAT DURING SURGERY, A FIBER OR LINT CAME FROM THE VISCOELASTIC'S CANNULA WHEN THE SURGEON WAS INSTILLING IT INTO THE PATIENT'S EYE. THE FIBER WAS REMOVED DURING SAME SESSION. NO PATIENT HARM WAS REPORTED. NO ADDITIONAL INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207716 PROVISC (IN DUOVISC) AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / ALCON N.V. NA 13J14L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK