BEUDAMED
    FDA Adverse Event Summary report: N

    CLEAR CARE PLUS WITH HYDRAGLYDE - HYDROGEN PEROXIDE CONTACT LENS SOLUTION

    MDR report key: 8008899 · Received October 25, 2018

    Report

    Report Number
    MW5080816
    Date Received
    October 25, 2018
    Date of Event
    May 18, 2017
    Report Date
    October 25, 2018
    Manufacturer
    ALCON RESEARCH, LTD.
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CLEAR CARE PLUS WITH HYDRAGLYDE CAUSED MY VISION TO BECOME EXTREMELY HAZY AND CLOUDY ABOUT AN HOUR AFTER PUTTING MY LENSES IN. UPON REMOVING THEM, THE HAZINESS HAS REMAINED AND I AM SCARED I'M GOING TO GO BLIND. I HAVE READ (B)(6) REVIEWS OF THIS PRODUCT, AND MANY OTHER CONSUMERS HAVE EXPERIENCED THE SAME THING. THIS HAZINESS IN MY VISION SEEMS TO BE GRADUALLY SUBSIDING, BUT THIS COMPANY NEEDS TO RECALL THIS PRODUCT. I FOLLOWED ALL OF THE DIRECTIONS PROPERLY AND NEUTRALIZED THE SOLUTION AND DIDN'T EXPERIENCE ANY BURNING OR STINGING UPON INSERTION. I COULD SEE GREAT AT FIRST AND MY LENSES FELT GREAT, BUT THEN A CLOUDY HAZE FORMED, AND THERE WERE RAINBOW HALOS AROUND LIGHTS. THIS IS A DEFECTIVE PRODUCT AND THE COMPANY IS STILL PRODUCING IT, UNACCEPTABLE. I HOPE I DON'T EXPERIENCE ANY PERMANENT ISSUES AS A RESULT OF TRYING CLEAR CARE PLUS WITH HYDRAGLYDE. DOCUMENT NUMBER: (B)(4). REPORT NUMBER: (B)(4). RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844208 CLEAR CARE PLUS WITH HYDRAGLYDE - HYDROGEN PEROXIDE CONTACT LENS SOLUTION ACCESSORIES, SOFT LENS PRODUCTS LPN ALCON RESEARCH, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1