BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUVUE OASYS WITH HYDRACLEARZ

    MDR report key: 1772191 · Received July 21, 2010

    Report

    Report Number
    MW5016830
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 20, 2010
    Report Date
    July 21, 2010
    Manufacturer
    JOHNS & JOHNSON VISION CARE, INC
    Product Code
    LPL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTREMELY DRY, ITCHY RED EYE-S- AFTER USING ACUVUE OASYS BRAND CONTACT LENSES. HAVE MADE 3 VISITS TO THE OPTOMETRIST WHO HAS TREATED ME FOR "INFECTION". HOWEVER, EACH TIME I START TO USE A NEW PAIR, I END UP WITH THE EXACT SAME SYMPTOMS. ONLY AFTER THE THIRD VISIT TO THE DOCTOR DID HE TELL ME THAT I HAVE AN ALLERGY TO THE SILICONE IN THIS CONTACT LENS. THIS CONTACT LENS IS BEING "PUSHED" BY EYE DOCTORS AS THE BEST FOR YOUR EYES BECAUSE, THEY ARE THINNER AND ALLOW FOR MORE AIR TO FLOW. HOWEVER, AFTER READING SOME OF THE BLOGS/POSTS, THERE ARE MANY PEOPLE WHO HAVE HAD ADVERSE SIDE EFFECTS FROM USING ACUVUE OASYS LENSES. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: VISION CORRECTION. EVENT ABATED AFTER USE STOPPED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUVUE OASYS WITH HYDRACLEARZ NONE LPL JOHNS & JOHNSON VISION CARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| S