BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS

    MDR report key: 1050084 · Received May 21, 2008

    Report

    Report Number
    MW5006971
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 21, 2008
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, AFTER EXPERIENCING HORRIBLY RED EYES AND SWOLLEN EYE LIDS FOR A FEW MONTHS, I DECIDED TO HAVE MY EYES CHECKED BY MY EYE DR. TO MY SURPRISE, SHE INDICATED I HAD AN ALLERGIC REACTION TO THE MATERIAL OF THE ACUVUE OASYS CONTACT LENS. I WAS SHOCKED. I HAVE WORN CONTACT LENSES FOR 22 YEARS, DIFFERENT BRANDS, AND NEVER HAD THE ISSUES I HAD EXPERIENCED WITH THESE LENSES. I DECIDED TO DO A BIT MORE RESEARCH TO SEE IF OTHERS HAD ISSUES I DID. MUCH TO MY SURPRISE, HUNDREDS OF PEOPLE HAVE BEEN EXPERIENCING THE SAME ISSUES AND SOME EVEN MORE SERIOUS AS I HAVE WITH THESE CONTACT LENSES. IN SOME CASES, THERE WAS A PERMEANT DAMAGE DONE TO SOME INDIVIDUALS' SIGHT FROM USING THESE LENSES. I DECIDED TO CONTACT JOHNSON & JOHNSON AS I WAS NOW CONCERNED THERE WERE DEFINITELY ISSUES WITH THE PRODUCT AND NOT JUST A FLUKE THAT I WAS ALLERGIC TO THEM. I WAS IMMEDIATELY BRUSHED OFF AND TOLD THAT ANYONE CAN EXPERIENCE ADVERSE REACTIONS TO LENS MATERIAL...EVEN SOLUTION. I DO BELIEVE THAT MORE TESTING NEEDS TO BE DONE WITH THESE LENSES. IT TOOK ABOUT 1 MONTH FOR MY ISSUES CAUSED BY THE ALLERGIC REACTION TO ACTUALLY START SHOWING. I AM NOT THE TYPE OF PERSON TO COMPLAIN ABOUT PRODUCTS THAT MAY NOT WORK FOR ME, HOWEVER, IN THIS PARTICULAR CASE, MY COMPLAINTS ARE DUE TO MY CONCERN FOR OTHERS WHO MAY NOT REALIZE THE ISSUES THAT THESE LENSES CAN CAUSE. PLEASE DO THE RIGHT THING AND TAKE SOME TIME TO TEST THESE CONTACTS MORE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: TO CORRECT VISION. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS CONTACT LENS LPL JOHNSON & JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Disability