BEUDAMED
    FDA Adverse Event Summary report: N

    CLEAR CARE PLUS HYDRAGLYDE

    MDR report key: 10270128 · Received July 13, 2020

    Report

    Report Number
    MW5095502
    Date Received
    July 13, 2020
    Date of Event
    January 1, 2020
    Report Date
    July 13, 2020
    Manufacturer
    CIBA VISION CORPORATION/ALCON LABORATORIES, INC.
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DESCRIPTION: I PURCHASED A BOTTLE OF CLEAN CARE PLUS HYDRAGLYDE TO USE AS SALINE SOLUTION BECAUSE I DIDN'T EVEN KNOW THERE WAS A SOLUTION WITH HYDROGEN PEROXIDE IN IT, AND I HAVE BEEN WEARING CONTACTS FOR OVER 20 YEARS. THE RED ON THE BOTTLE DIDN'T ALERT ME TO ANYTHING. I JUST THOUGHT THE BOTTLE WAS BLUE AND RED. I DIDN'T THINK I HAD TO READ THE INSTRUCTIONS ON SOMETHING AS SIMPLE AS SALINE SOLUTION. WELL I WOKE UP THIS MORNING AND REACHED FOR THIS SOLUTION WHILE SUPER GROGGY AND RINSED ONE OF MY CONTACTS WITH IT AND PUT IT IN MY EYE. IT FELT LIKE I WAS POURING BOILING WATER INTO MY EYE. IT HURT SO BAD. I IMMEDIATELY TOOK THE CONTACT OUT AND READ THE LABEL AND THAT'S WHEN I DISCOVERED IT. I'M JUST REALLY UPSET. MY EYE FEELS OK NOW AFTER RINSING IT FOR A HALF HOUR. BUT SOMETHING LIKE THIS SHOULD BE MONITORED BETTER. IF THE BOTTLE HAD THE WORD WARNING. REALLY BIG ON THE PACKAGE SO THAT IT CAUGHT PEOPLE'S ATTENTION TO READ IT THEN THAT WOULD BE BETTER THAN JUST PUTTING THE WARNING IN SMALL WRITING ON A RED LABEL. PEOPLE DON'T OFTEN ASSOCIATE COLORS WITH WARNINGS. THAT OR ELSE PUT THIS STUFF BEHIND THE PHARMACY COUNTER. BUT SOMETHING NEEDS TO CHANGE, THAT WAS EXTREMELY PAINFUL. MEDICATION ADMINISTERED TO OR USED BY THE PATIENT: NO. OUTCOME: FINAL OUTCOME: TEMPORARY HARM/INJURY FINAL OUTCOME COMMENT: EYE BURNED FOR ABOUT A HALF HOUR. FEELS BETTER NOW BUT STILL CAN'T PUT MY CONTACTS BACK IN. WHEN AND HOW WAS ERROR DISCOVERED: I ACCIDENTALLY USED THE PRODUCT ON MY EYE NOT KNOWING WHAT IT REALLY WAS AND IT BURNED MY EYE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732927 CLEAR CARE PLUS HYDRAGLYDE ACCESSORIES, SOFT LENS PRODUCTS LPN CIBA VISION CORPORATION/ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1