BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MW5057433

    MDR report key: 5187169 · Received October 26, 2015

    Report

    Report Number
    MW5057433
    Event Type
    Injury
    Date Received
    October 26, 2015
    Date of Event
    September 8, 2012
    Report Date
    September 8, 2012
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THIS MORNING MY WIFE DID SOMETHING SHE HAS DONE FOR MORE THAN 30 YEARS, PLACING CONTACT LENS IN HER EYES. BUT THIS TIME IT WAS DIFFERENT. SHE SUFFERED EYE BURNING AND EXCRUCIATING PAIN WHEN DOING THIS. THE CAUSE OF THE PROBLEM IS THE LENS CLEANING SOLUTION CALLED CLEAR CARE BY CIBA VISION CORP. SHE THOUGHT THAT IT WAS JUST ANOTHER CLEANING SOLUTION LIKE THOSE SHE HAS USED FOR DECADES BECAUSE THE CARTON PACKAGE LOOKS JUST AS USUALLY WITHOUT OBVIOUS WARNING MESSAGE ON THE CARTON PACKAGE. MEDICATION ADMINISTERED TO OR USED BY THE PT. IT WAS THE FIRST TIME MY WIFE USED THE CLEAR CARE PRODUCT. NATURALLY, THE FOCUS WAS ON THE PRODUCT. AFTER TAKING A CLOSE LOOK, I SAW A NON-OBVIOUS (SMALL FONT SIZE AND BLACK FONT COLOR) MESSAGE ON THE PACKAGE, WARNING/PRECAUTIONS: SEE INSIDE OF THIS CARTON. INGREDIENTS CONTAINS VERY CORROSIVE AGENT OF 3% HYDROGEN PEROXIDE, SOMETHING THAT YOU NEVER WANT YOUR EYES TO CONTACT WITH. WHEN I OPENED THE PACKAGE INSIDE OUT, THERE IS INDEED WARNING MESSAGE WRITTEN IN RED. IT SAYS THAT FOLLOWING THE USUAL STEP OF CLEANING, THERE IS A EXTRA 6 HOUR LONG STEP TO NEUTRALIZE THE SOLUTION ON THE LENS. WITHOUT THE EXTRA STEP, BURNING AND STINGING WILL RESULT. BUT IT WAS TOO LATE. DAMAGE HAS BEEN DONE, AND I DON'T KNOW THE LONG TERM CONSEQUENCE TO HER EYE. PT CONSULTING PROVIDED: UNK. REPORTER'S RECOMMENDATIONS: NOT EVERYONE WILL GO THE EXTRA LENGTH TO OPEN THE PACKAGE INSIDE OUT TO READ INSIDE MESSAGE. MY WIFE IS LIKELY NOT ALONE. IN FACT, REPORTS OF THE SAME INCIDENTS SHOW UP AGAIN AND AGAIN ON THE WEB. IT APPEARS TO BE A WIDE SPREAD ISSUE FOR CONTACT LENS USERS. SOMETHING SHOULD BE DONE TO SOLVE THIS PROBLEM, SOONER RATHER THAN LATER. HERE IS A SIMPLE, ONCE AND FOR ALL SOLUTION: TAKE IT OFF THE SHELF. IF IT IS NOT POSSIBLE, THE PACKAGE SHOULD BE REDESIGNED WITH THE WARNING MESSAGE IN BIG AND RED FONT IN THE FRONT OF THE PACKAGE. ERROR RESULTED IN TREATMENT OR INTERVENTION; TEMPORARY PT HARM. (B)(6).

    Patients

    Seq Age Sex Outcome Treatment
    1