Sunday, May 3, 2015

Memo to FDA: Popular len cleaning solution Clear Care continues to burn people's eyes

By guest blogger Michael Cohen: I don't think we've ever run into a situation like this where so many people have been harmed using a product, yet nothing seems to be getting done about to repackage the lens cleaning solution to reduce potential for errors.

Memo to FDA: Popular len cleaning solution Clear Care continues to burn people's eyes

By guest blogger Michael Cohen:

Earlier this year we wrote about large numbers of contact lens wearers accidentally burning their eyes after mistakenly rinsing or soaking their lenses with a popular lens cleaning and disinfectant solution called Clear Care (Ciba Vision). This past Friday we heard from yet another lens wearer who had burned her eyes, so I thought it would be worthwhile to do an update.  

Clear Care is 3% hydrogen peroxide, which should never be used as a contact lens rinse or to soak lenses in a flat lens holder. The Clear Care website does mention that if you do either, it can burn or sting your eyes. In truth, it does much more than that! Doing so can cause severe burning and chemical injuries to the eye, sometimes with corneal damage or inflammation that requires treatment. Also, the pain associated with this error is so bad that it’s often described as “scorching” or “searing” or “the worst pain I ever experienced.” This is a problem that is quite familiar to eye doctors and ER personnel.

Clear Care is supposed to be used to soak contact lenses for at least six hours in a special accompanying lens case that holds a small platinum ring. The ring creates a bubbling action which actively releases oxygen, cleans and removes protein from lenses and neutralizes the solution, killing bacteria in the process. After the disinfecting and neutralizing step is completed, the lenses can be removed from the case and placed in the eyes. Contacts must never be rinsed with the hydrogen peroxide solution and placed directly into the eye. The entire disinfecting and neutralizing step must be completed.

Unfortunately, it’s all too easy for contact lens users to mistake containers of Clear Care or generically equivalent solutions for one of the similar looking buffered contact lens rinsing or cleaning solutions. These are in fact supposed to be used directly with lenses as a rinse or soak. Consumers often mention they did not know about the difference, since in stores or supermarkets, Clear Care is stored along with the buffered solutions and the containers have similar wording and graphics. For example, Clear Care says “No Rub,” meaning you don’t have to rub the lenses clean, and “Cleaning and Disinfecting.” The buffered solutions have similar wording that says, “Easy Rub” and also mentions they are “Cleaning and Disinfecting.” All of these solutions also have pictures of contact lenses.

Other reported cases have occurred when a buffered solution user tries to borrow a friend or relative’s rinse when they run out of their own or when visiting someone who also wears contact lenses. In the bathroom they see the Clear Care bottle with the contact lens picture and just assume it’s the same as their ordinary solution for rinsing or soaking. Many of the reported cases have involved teens who might not exercise as much care as they should in reading labels. In addition, sometimes people function in what I call “automatic mode.” One patient wrote that although he had been using Clear Care for a while, he accidentally reverted to an old habit he had with the buffered rinse he previously used, grabbing the bottle, rinsing his lenses and putting them in his eye.

Although instructions for proper use of Clear Care are printed on the container label, people don’t always read labels as they should. One problem with Clear care is that you have to turn the container to see any warnings about not using it in the eye. But you probably wouldn’t do that if you didn’t know there were any warnings on the other side.

Another problem, even if you do read the print, is that the wording is too low key to consistently communicate the danger of getting hydrogen peroxide in the eye. For example, it says “use only lens case provided. But nowhere does it actually say, “WARNING! Putting Clear Care in your eye will cause severe burns.” Such a statement should be typed boldly, in bold red upper case type, right on the front of the outside carton as well as on the front of the bottle. Warnings should also be printed in other locations so it can be seen no matter how the product is oriented.

A different container shape would also be helpful so people won’t see this product as just another multipurpose cleaner and disinfectant. The bottle does have a red spout which the company told me was supposed to serve as a warning. But how many people would know that a red spout is supposed to mean there is some kind of “danger” in using the product incorrectly?

Despite communications this past summer with FDA and the manufacturer to request improved packaging of Clear Care, it appears that no changes have occurred since we first wrote about it. Yesterday I purchased bottles of Clear Care at neighborhood Walgreens, CVS and Rite Aid stores. There were no changes in the labeling or packaging that I could see, when I compared them to bottles I purchased last June. I don't think we've ever run into a situation like this where so many people have been harmed using a product, yet nothing seems to be getting done about to repackage the product to reduce potential for errors. 

I want to again warn contact lens wearers about this risk, which could affect them as well as friends or family members who might not know about Clear Care. I will also be urging manufacturers of these products as well as the FDA to do more to assure safe if these products are to remain on the market.

For information on ISMP's consumer web site go www.consumermedsafety.org

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About this blog

Check Up covers regional health news and a wide array of healthcare topics from pharmaceutical happenings to patient safety. Read about some of our bloggers here.

Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Michael R. Cohen, R.Ph. President, Institute for Safe Medication Practices
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