FDA Adverse Event Summary report: N

CLEAR CARE

MDR report key: 2982729 · Received February 23, 2013

Report

Report Number
MW5029165
Date Received
February 23, 2013
Date of Event
February 23, 2013
Report Date
February 23, 2013
Manufacturer
CIBA VISION
Product Code
LPN
Report Source
Voluntary report
Reporter Location
IL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I USED CLEAR CARE SOLUTION FOR SOFT CONTACT LENSES, AND IT REALLY BURNT MY EYE. I WAS IN SO MUCH PAIN IT WAS A MIRACLE I COULD CALM DOWN ENOUGH TO GET MY CONTACT OUT OF MY EYE. THIS HAPPENED THIS MORNING AND 7 HOURS LATER I AM STILL IN A LOT OF PAIN. WHILE THERE HAVE BEEN SOME CHANGES TO THE PACKAGING OF THE CLEAR CARE SOLUTION, I DON'T FIND THAT THE CHANGES ARE NEAR ADEQUATE CONSIDERING HOW DIFFERENT THIS SOLUTION IS FROM "NORMAL" CLEANING AND DISINFECTING SOLUTION. THE SOLUTION BOTTLE ITSELF HAS A SMALL WARNING TOWARDS THE TOP, BUT BY THE TIME I LOOKED AT THIS BOTTLE, I HAD REMOVED MY CONTACTS AND REALLY COULDN'T SEE. THE BOTTLE OF SOLUTION COMES INSIDE A CARDBOARD BOX, AND THIS BOX HAS ABSOLUTELY NO WARNING ON THE OUTSIDE. THE ONLY WARNING IS INSIDE THE BOX IN FINE PRINT, AND YOU HAVE TO TEAR THE BOX APART TO READ IT. THE TIME WHEN I COULD HAVE SEEN THIS WARNING WOULD BE WHEN MY CONTACTS WERE IN MY EYES, WHEN I WAS AT THE PHARMACY, CHOOSING A PRODUCT. NOT WHEN MY CONTACTS WERE ALREADY OUT AND I REMOVED THE BOTTLE FROM THE CARDBOARD. THIS SEEMS LIKE A SIMPLE CONCEPT FOR A COMPANY WHOSE MARKET IS PEOPLE WITH POOR VISION. I KNOW MANY COMPLAINTS HAVE BEEN MADE ABOUT THIS PRODUCT, AND THAT IS BECAUSE FURTHER CHANGES NEED TO BE MADE TOT HE PACKAGING. THE FACT IS, THIS PRODUCT LOOKS EXACTLY LIKE ANY SOLUTION I HAVE USED FOR THE PAST 15 YEARS, SO I HAD NO REASON TO QUESTION IT. IT WAS SOLD RIGHT NEXT TO ALL THE OTHER 'SAFE' SOLUTIONS. IT ISN'T THE SAME, IT ISN'T SAFE, AND IT NEEDS TO LOOK DIFFERENT. IN FACT, WHY DOES THIS PRODUCT EVEN EXIST. IT REMAINS TO BE SEEN WHETHER OR NOT I WILL NEED TO GO TO THE DOCTOR ABOUT THIS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
78962 CLEAR CARE CLEANING AND DISINFECTING SOLUTION LPN CIBA VISION 18125

Patients

Seq Age Sex Outcome Treatment
1 28 YR Other