BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEAN AND CLEAR SOLUTION

    MDR report key: 2756233 · Received September 19, 2012

    Report

    Report Number
    MW5027007
    Event Type
    Injury
    Date Received
    September 19, 2012
    Date of Event
    January 1, 2012
    Report Date
    July 10, 2012
    Product Code
    LPN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HADN'T WORN MY CONTACTS IN ABOUT 6 MONTHS. I LOOKED IN MY CABINET FOR SALINE SOLUTION TO PUT MY CONTACTS IN AND GRABBED MY CLEAN AND CLEAR SOLUTION. I REMEMBERED BEING TOLD NOT TO PUT IT IN MY EYE, BUT I WASN'T CERTAIN. SO I CHECKED THE PACKAGING AND LABELING. NOTHING SAID "DO NOT PUT DIRECTLY INTO EYE." LIKE EVERYONE ELSE, MY EYE BURNED, STUNG, TURNED RED. I DON'T KNOW WHAT MY EYE WILL LOOK LIKE TOMORROW, BUT I'M GLAD I'M NOT THE ONLY ONE WHO HAS HAD THIS PROBLEM. THE LABELING NEEDS TO BE CHANGED. IF A PRODUCT IS DANGEROUS IF USED A CERTAIN WAY, THE WARNING SHOULD BE CLEAR. I PUT THE PRODUCT DIRECTLY IN MY EYE! THEN I DID A (B)(6) SEARCH AND FOUND YOUR ARTICLES ON THIS. REPORTER'S RECOMMENDATIONS: CLEAR WARNING "DO NOT PUT DIRECTLY IN EYE". I LOOKED FOR A WARNING LIKE THIS AND COULDN'T FIND ONE. I FIGURED IF THE WARNING WAS THAT IMPORTANT, IT WOULD HAVE BEEN CLEARLY, VISIBLY STATED ON THE BOTTLE. WHO KEEPS THE PACKAGING AFTER THEY USE THE BOTTLE? (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAN AND CLEAR SOLUTION CONTACT LENS SOLUTION LPN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R