BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS PLUS HYDRACLEAR

    MDR report key: 2467551 · Received February 20, 2012

    Report

    Report Number
    MW5024369
    Event Type
    Injury
    Date Received
    February 20, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 20, 2012
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT "ACUVUE OASYS PLUS" BY J AND J HAS CAUSED ME BAD ALLERGIC EYE REACTIONS. I HAVE EXPERIENCED THE FOLLOWING FROM THESE CONTACT LENSES: UNCOMFORTABLE, BLURRY VISION, LIGHT SENSITIVITY, HARD TO FOCUS, PUS BUILDUP IN EYES, ITCH, EASILY PRONE TO SCRATCHES. THE SAME REPORTS ARE ALSO FOUND IN CONSUMER REVIEW FORUMS ONLINE. I HAVE WORN CONTACT LENSES FOR OVER 6 YEARS. THIS BRAND IS NOT SAFE FOR MY EYES AND MANY OTHER PEOPLE'S EYES TOO. DATES OF USE: (B)(6) 2011 - (B)(6) 2012. TREATMENT OF NEARSIGHTEDNESS, DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS PLUS HYDRACLEAR LENS, -5.50 LPL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other