BEUDAMED
    FDA Adverse Event Summary report: N

    AIR OPTIX NIGHT AND DAY AQUA

    MDR report key: 3599368 · Received January 23, 2014

    Report

    Report Number
    MW5034030
    Date Received
    January 23, 2014
    Date of Event
    November 2, 2013
    Report Date
    January 21, 2014
    Manufacturer
    CIBA VISION
    Product Code
    LPM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT: CIBA VISION AIR OPTIX NIGHT AND DAY AQUA CONTACTS, LOT NUMBER: 31074785, EXPIRATION DATE: 03/2018. THERE ARE SIX LENSES PER BOX AND I USE THE SAME PRESCRIPTION IN BOTH EYES. ON (B)(6) 2013, I USED TWO LENSES FROM THIS NEW BOX OF CONTACTS UPON WAKING. I NOTICED EYE IRRITATION BY NOON. AT 2:00PM, I STARTED HAVING SIGNIFICANT REDNESS AND DISCHARGE IN BOTH EYES. I REMOVED THE CONTACTS AND USED SALINE TO RINSE MY EYES, BUT DID NOT GET MUCH RELIEF. BY 6:00PM THAT EVENING, MY CONDITION WORSENED. MY EYES WERE EXTREMELY RED, MY EYELIDS WERE SWOLLEN AND RED AND I EXPERIENCED A LOT OF SEVERE PAIN. I CALLED THE DOCTOR IMMEDIATELY AND WAS PRESCRIBED ANTIBIOTIC EYE DROPS. IT TOOK 3 DAYS ON ANTIBIOTICS BEFORE I SAW AN IMPROVEMENT. EVENTUALLY, MY EYES GOT BETTER AFTER A FULL COURSE OF ANTIBIOTICS. AFTER 10 DAYS, I THREW OUT MY CONTACT SOLUTION, SALINE, AND CONTACT CASE AND STARTED FRESH. I PUT IN A FRESH PAIR OF CONTACTS FROM THE SAME BOX UPON WAKING. AGAIN, I BEGAN EXPERIENCING DISCOMFORT IN MY EYES. I REMOVED THE CONTACTS AFTER ABOUT 4 HOURS AND WAS STILL FEELING IRRITATION, BY THE EVENING MY EYES STARTED TURNING RED AND DEVELOPING A DISCHARGE, BUT NOT AS BAD AS THE FIRST INCIDENT. I BELIEVE THIS IS BECAUSE I REMOVED THE CONTACTS SOONER. I HAD SOME MEDICINE LEFT FROM MY FIRST ROUND OF ANTIBIOTICS SO I BEGAN USING IT SO MY CONDITION WOULD NOT WORSEN. I CALLED THE DOCTOR AND GOT AN APPOINTMENT FOR THE NEXT MORNING. HE PRESCRIBED A DIFFERENT ANTIBIOTIC FOR ME. I THOUGHT MAYBE MY MAKEUP WAS THE PROBLEM, SO I GOT NEW MAKEUP BRUSHES, BUT I REFRAINED FROM WEARING ANY MAKEUP ANYWAY (I HAD NOT BEEN USING ANY MAKEUP SINCE THE FIRST INCIDENT). I THOUGHT THAT I WOULD ALSO REFRAIN FROM TRYING TO WEAR CONTACTS UNTIL JANUARY (MORE THAN 4 WEEKS AFTER I COMPLETED MY NEW COURSE OF ANTIBIOTICS). ON (B)(6), I USED THE LAST PAIR OF CONTACTS FROM THE BOX. I OPENED FRESH CONTAINERS OF CONTACT SOLUTION AND SALINE AND GOT A NEW CONTACT CASE. AGAIN, MY EYES WERE FEELING DISCOMFORT. I REMOVED THE CONTACTS AFTER A FEW HOURS OF WEAR AND BEGAN AGAIN TO EXPERIENCE THE SAME SYMPTOMS AND HAD TO GO ON ANTIBIOTICS AGAIN. BASED ON MY EXPERIENCE, I AM CONFIDENT THAT THE CONTACT LENSES WERE SOMEHOW DEFECTIVE. I HAVE BEEN WEARING THIS BRAND OF CONTACTS FOR 7 YEARS AND NEVER EXPERIENCED ANY PROBLEMS AT ALL. I DO NOT WEAR MY CONTACTS TO SLEEP, BUT REMOVE AND DISINFECT THEM EVERY EVENING BEFORE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55015 AIR OPTIX NIGHT AND DAY AQUA AIR OPTIX NIGHT AND DAY AQUA LPM CIBA VISION 31074785

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability