BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACUVUE OASYS

    MDR report key: 1013931 · Received March 13, 2008

    Report

    Report Number
    MW5005892
    Event Type
    Other
    Date Received
    March 13, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 13, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER OVER A WEEK USE OF ACUVUE OASYS CONTACT LENS, MY RIGHT EYE STARTS TO ITCH, HAVE CONSTANT SECRETIONS AND SWELLING. I HAD TO STOP WEARING IT. WHEN IT WENT AWAY FOR A FEW DAYS WHILE I WAS WEARING MY OLD CONTACT LENS, B&L'S SOFLENS 66, I TRIED THE OASYS AGAIN AND AGAIN AFTER A WEEK, I STARTED TO HAVE THE SAME PROBLEM WITH MY RIGHT EYE AND THIS TIME GOT MUCH WORSE. I HAD TO USE THE EYE DROPS AND OINTMENT FOR THE EYE. THERE IS DEFINITELY SOME SORT OF ALLERGIC REACTIONS TO THE LENS AND THEY NEED TO DO MORE CLINICAL TRIALS AND TESTING BEFORE AFFECTING GOD KNOWS HOW MANY PEOPLE. FREQUENCY: DAILY WEAR. DATES OF USE: 1. 10 DAYS, 2. 9 DAYS. DIAGNOSIS OR REASON FOR USE: CORRECT NEARSIGHT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: 1: YES, 2: YES. EVENT REAPPEARED AFTER REINTRODUCTION: 1: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS UNK LPL JOHNSON & JOHNSON B005W17
    2 ACUVUE OASYS UNK LPL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other