Painful eye injuries with improper use of Clear Care

 

People who wear contact lenses may assume that all multipurpose cleaning and disinfecting solutions used for rinsing and soaking lenses are the same. After all, they are stored side-by-side on supermarket and pharmacy shelves. But they are not all the same—particularly regarding how they are used—and serious injuries can occur if these products are used improperly.

 

Recently, a young woman who was staying at a friend’s house noticed a bottle of contact lens solution in the bathroom. She removed her contacts, placed them in her flat contact lens case, and added the solution found in her friend’s bathroom. The solution was CLEAR CARE (CIBA VISION, a Novartis Company), a cleaning and disinfecting product. To the woman, the product. looked like any other contact lens cleaning solution. The label had a picture of a contact lens on it, and it seemed to be the same shape and size as other contact lens solutions. The following morning, the woman put one of the contacts in her right eye and experienced excruciating pain and burning. Her eye clenched shut, delaying removal of the contact lens. The problem was discovered when the woman called her eye doctor, mentioned the product she had used, and described how she had soaked her lenses with the solution in her flat contact lens holder.old.cc

The doctor pointed out that Clear Care is 3% hydrogen peroxide, which will cause severe burning if used directly in the eyes or as a soaking agent in typical contact lens cases. The Clear Care case has a built-in neutralizer—a ring of platinum that reacts with hydrogen peroxide—that causes effervescence and changes hydrogen peroxide into water. The process takes about 6 hours, and only the special accompanying lens case can be used to neutralize the hydrogen peroxide. 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. As hundreds of Internet descriptions and FDA MedWatch reports demonstrate, not doing so can cause pain, burning, and chemical injuries to the eye, including tissue injuries. Almost all cases have occurred when patients confused Clear Care or a generic product with other cleaning and disinfecting solutions, including saline irrigating solutions, despite manufacturer labeling with warnings that are intended to help avoid misuse.

With these ongoing reports, we want to warn contact lens wearers about this risk, and we urge manufacturers of these products and FDA to do more to assure safe use if they remain on the market. One required improvement should be better design and placement of the warnings. In the case of Clear Care, a red band at the top of the container (see picture) states, “Use only lens case provided. Do not rinse lens with Clear Care prior to insertion.” You must turn the container to see the entire statement, and if read, the statement may not be a clear warning. Some will think, “Why use the special lens case when I have my own case.” As for the statement about not rinsing lens with the solution prior to insertion, no doubt some will misinterpret this statement to simply mean they need not rinse the lenses that have been soaking in the solution prior to insertion. Those who do not routinely rinse their lenses with saline prior to insertion may simply ignore this statement, thinking it doesn’t apply to them. It should also be mentioned that under the bottle's cap, there is a small red spout that is meant to help people differentiate this product from others. However, that doesn't seem to be much of a deterrent since problems are still occurring.

Warnings should be printed in their entirety on the product’s front label panel near the product name, as well as in other locations so it can be seen no matter how the product is oriented. Consumers might not turn the product to look for a warning if they don’t know the warnings are present. With Clear Care, there is also a red paper ring on the neck of the bottle that reads, “Use only lens case provided,” “Do not put Clear Care directly into the eye,” and “Do not rinse lens with Clear Care prior to insertion.” However, again, the bottle or ring must be turned to read all the statements, and to some users, these may not seem important. The ring may also be removed or come off if the paper gets wet, as it might if the product is used near the bathroom sink.

We’d also like to see much stronger warnings on both the bottle and the carton panels and flaps. The words “WARNING” or “DANGER” should precede a statement about the consequences of not following directions. It should also be noted that some people might not be able to read label instructions without their contacts in place. A different container shape would also be helpful so people won’t see this product as just another multipurpose cleaner and disinfectant. Human factors testing is also in order.

Created on June 3, 2010

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