BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISINE CONTACT LENS

    MDR report key: 701668 · Received April 17, 2006

    Report

    Report Number
    2246407-2006-00003
    Event Type
    Other
    Date Received
    April 17, 2006
    Date of Event
    March 28, 2006
    Report Date
    April 4, 2006
    Manufacturer
    PFIZER, INC.
    Product Code
    LPN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CONSUMER USED A 3 DROPS OF VISINE CONTACT LENS (GLYCERIN), HYDROXYPROPYLMETHYLCELLULOSE) FOR "2 1/2 WEEKS OFF AND ON" BEGINNING ON AN UNSPECIFIED DATE IN MAR 2006, HIS EYES WERE BLOODSHOT AND PAINFUL, AND HIS VISION BLURRED. THE PRODUCT RAN DOWN HIS FACE AND HE HAD "A CHEMICAL BURN ON HIS EYES WHERE THE VISINE CAME IN CONTACT WITH HIS SKIN. HIS FACE WAS "BRIGHT RED". THAT SAME DAY, HE WENT TO THE EMERGENCY ROOM WHERE HIS EYES WERE IRRIGATED AND THE SOLUTION TESTED FOE THE PRESENCE IF CHEMICALS (RESULTS UNSPECIFIED). OTHER UNSPECIFIED VISION TESTS WERE PERFORMED (RESULTS UNK) . PRODUCT USE WAS DISCONTINUED ON 28MAR2006. AS OF 29MAR2006., THE FACIAL REDNESS AND BLURRED VISION WERE IMPROVING. ALL OTHER EVENTS WERE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISINE CONTACT LENS CONTACT LENS PRODUCT LPN PFIZER, INC. UNK 0105177

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other