BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 2062235 · Received March 17, 2011

    Report

    Report Number
    3002037047-2011-00010
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    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
    IT
    Reporter Occupation
    OTHER

    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 ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. THE BATCH RECORD REVIEW SHOWED THAT ALL TESTING RESULTS ARE WITHIN SPECIFICATIONS. A RETENTION SAMPLE, OF THIS BATCH, WAS TESTED AND ALL RESULTS CONFORM TO THE SPECIFICATIONS FOR THE TESTED PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE PRODUCT WAS LESS TRANSPARENT THAN USUAL. FOREIGN SUBSTANCES ("SNOW FLAKES" LIKE) WERE VISIBLE WHEN THE VISCOELASTIC WAS INJECTED IN THE ANTERIOR CHAMBER. SOON AFTER, THE VISCOELASTIC WAS REMOVED FROM THE ANTERIOR CHAMBER AND REPLACED WITH ANOTHER VISCOELASTIC WHICH WAS NOT DEFECTIVE. PT IMPACT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/ S.A.ALCON-COUVREUR N.V. NA 10F22B

    Patients

    Seq Age Sex Outcome Treatment
    1 BETABIOPTAL EYE DROPS