BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOAT

    MDR report key: 2032424 · Received March 25, 2011

    Report

    Report Number
    3002037047-2011-00011
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 28, 2011
    Manufacturer
    ALCON-BELGIUM/S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P840064
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT HE HAD THREE PATIENT'S WHO EXPERIENCED ENDOPHTHALMITIS FOLLOWING SURGERY IN WHICH THIS PRODUCT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention VISCOELASTIC %1 (BRAND UNKNOWN)