BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEAR CARE

    MDR report key: 6056936 · Received October 25, 2016

    Report

    Report Number
    MW5065612
    Event Type
    Other
    Date Received
    October 25, 2016
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPN
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLEAR CARE SOLUTION BY ALCON. I HAVE BEEN WEARING CONTACT LENSES FOR 47 YEARS AND HAVE NEVER HAD ANY PROBLEM. I RECENTLY BOUGHT WHAT I THOUGHT WAS SALINE SOLUTION BECAUSE IT WAS SHELVED WITH AND PACKAGED IDENTICAL TO THE OTHER SALINE SOLUTIONS. I USE IT TO CLEAN MY LENSES AND WHEN I PUT THE LENS IN MY EYES I HAD AN IMMEDIATE AND VIOLENTLY PAINFUL BURNING IN MY EYE. I WENT TO EMERGENCY WHERE THEY FLUSHED MY EYE FOR ABOUT A HALF AN HOUR. THREE DAYS LATER I STILL HAVE REDNESS AND BURNING AND HOPE THAT THERE WAS NO PERMANENT DAMAGE TO MY EYE. THE PACKING AND LABELING IS INADEQUATE AND IRRESPONSIBLE. I HAVE SINCE READ DOZENS OF REPORTS OF SIMILAR EPISODES FOR MANY YEARS AND NOTHING HAD BEEN DONE TO RECTIFY THIS SITUATION. DOES SOMEONE HAVE TO GO BLIND OR LOSE AN EYE BEFORE ALCON DOES THE RIGHT THING AND CHANGES ITS PACKAGING. MEDICATION ADMINISTERED TO OUR USED BY THE PATIENT: NO. OUTCOME: FINAL OUTCOME. TEMPORARY HARM/INJURY. FINAL OUTCOME COMMENT: NOT SURE IF THERE WILL BE PERMANENT DAMAGE. WHERE DID THE ERROR OCCUR: PATIENT HOME. WHEN AND HOW WAS ERROR DISCOVERED: EXTREME PAIN AND BURNING OF MY EYE. REPORTER'S RECOMMENDATIONS: RELABELING REPACKAGING AND SHELVED AWAY FROM NORMAL CONTACT LENS SOLUTIONS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706412 CLEAR CARE CONTACT LENS SOLUTION LPN ALCON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1