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Courtesy of the ISMP
Ciba Vision, makers of Clear Care contact lens cleaner, recently updated the product's packaging and labels. But a patient safety group says the changes aren't enough to halt reports of painful eye injuries.
Amid ongoing reports of burning eyes and emergency injuries, the makers of a popular contact lens solution have failed to adequately warn consumers about the dangers of using the product improperly, a patient safety group says.
Labels on bottles of Clear Care contact lens cleaner, sold by Ciba Vision, don’t carry a strong enough caution that the 3 percent hydrogen peroxide solution shouldn’t be used directly in the eyes, or clear enough warnings that it must be used only with the product’s proprietary case that neutralizes the solution.
That's according to the Institute for Safe Medication Practices, a nonprofit medication safety agency that has been lobbying for two years to get the firm to bolster its warning labels.
“It’s definitely not adequate. Obviously we’re still hearing these things,” said Michael R. Cohen, president of the ISMP.
Minor label changes were made last year, but Cohen said patients to continue to report accidentally putting the caustic chemical in their eyes, causing severe pain and, in some cases, serious harm. The reports range from dozens of formal complaints filed with government health officials to anecdotal surveys of random groups of contact lens users.
“This isn’t just a trickle of reports, it’s a gusher,” said Cohen, who said he has heard, seen or reviewed hundreds of complaints about Clear Care effects since 2010. “I think it probably ranks up there with the largest number we have ever seen for one product issue.”
However, officials with Ciba Vision, a Novartis company, and the federal Food and Drug Administration, say the firm has updated its labeling several times, most recently in 2011, and that the cautions are now strong enough.
“We believed that these changes were adequate to communicate the warnings to the end users,” said FDA spokeswoman Sarah Clark-Lynn.
The bottles now include a red warning dubbed “Important,” clear instructions to use only the special case and not to put the product directly in the eye. That's in addition to a cardboard collar that warns of potential misuse.
“The new package and label more prominently display the 3 percent hydrogen peroxide content and draw attention to possible consequences (like burning and stinging) of misuse,” said Elizabeth Power, a spokeswoman for Novartis. The product has been used for 30 years, she added.
At least 110 reports of eye problems caused by Clear Care have been reported since 2000 through the federal Food and Drug Administration’s MAUDE device monitoring system, including more than a dozen filed in the last half of 2011 and early 2012, after the packaging was altered. Because the FDA’s system is voluntary, the numbers likely represent a fraction of actual cases, perhaps as little as 1 percent, experts have estimated.
Many of the MAUDE reports describe confusion because Clear Care bottles look the same and are sold near other multipurpose contact lens solutions used for rinsing and soaking lenses. Those products can be used directly in the eye with no problem.
However, Clear Care is a cleaning solution that uses 3 percent hydrogen peroxide to remove dirt and film from contact lenses. It uses a special holder outfitted with a platinum ring that neutralizes the peroxide after about six hours. Instructions on the bottle clearly say that Clear Care should only be used with the special case and never on lenses put immediately into the eye.
When consumers fail to follow those directions, the results are immediate -- and excruciating.
“My eye slammed shut like I had acid in it and it took me 5 minutes to dig it out,” said a user in a MAUDE report filed July 26, 2011. “I believe there should be a huge caution banner across the bottle so consumers understand the result of not using their ‘special case’ is that your eye will be burned with peroxide.”
Several consumers reported that they rushed to hospital emergency rooms, where they were diagnosed with chemical burns, corneal ulcerations and other problems. Typical treatment included eye patches and antibiotic eye drops.
It’s an easy mistake to make, said Nancy Metcalf, a senior program editor for Consumer Reports whose 24-year-old daughter was visiting from college a couple years ago and accidentally used Clear Care directly in her eyes.
“I could hear her screaming,” Metcalf recalled. “She was up in the bathroom screaming. I jammed her eye under the faucet. Her eyes were burning for a couple of days.”
Metcalf still uses Clear Care, which she says is a great product for removing deposits and films from the lenses. But she also makes certain not to mix it up with her multipurpose contact solutions.
Hydrogen peroxide will cause a caustic burn if it gets in the eyes, confirmed Dr. Thomas Steinemann, a clinical correspondent for the American Academy of Ophthalmology and a professor of ophthalmology at MetroHealth Medical Center in Cleveland.
“Holy cow, if you put the lens in your eye with fresh peroxide on it, you might as well have lighted a fire in your eye,” he said.
But Steinemann also said it’s up to the 36 million to 38 million U.S. contact lens wearers to be aware of what product they’re using and how it works before it gets anywhere near their delicate eye tissue. He recommends consulting an eye care expert before using any new product.
“I hate to say it, but the burden of responsibility is on the user,” Steinemann said. “If you don’t know what you’re doing, you shouldn’t be doing it.”
Cohen, on the other hand, would like to see Ciba Vision add labels that say “Danger!” or “Warning!” to the Clear Care bottles. Even better, the firm should redesign the packaging so that the nozzle of the bottle can fit only into the special case.
“We’re talking about unsuspecting kids and others who use what they think is contact lens soak and wind up in the ER in excruciating pain,” he said. “Seems to me this product should either be a prescription item or redesigned to make it impossible.”
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I also use this product and have for years in the US. Once when extremely tired I made the mistake of using it improperly. My first reaction after the burning shock was to grab a bottle of saline and repeatedly wash out my eye. After that I said, "Was I ever stupid!!"
Now living in the Netherlands I use the same product but the name and labeling is different. The top is red but there is no major warning sign. But Europe, not being an overly litigious society, expect people to read the instructions and use good common sense.
As for people complaining of burning even after 6-8 hours of soaking, there may be other factors such as dry eyes or allergies causing that problem.
Agreed, could be allergies or dry eyes causing burning after 6-8 hours of soaking. Or, they didn't follow the instructions and overfilled the case, causing unneutralized solution to overflow around the cap. Just rinse with another saline before inserting lenses (as indicated in the instructions.)
We need to quit protecing the stupid
Sorry no excuse for those who are just grabbing a bottle and using. If I am putting something in my eye you better believe I'm going to read what I have in my hand first to make sure A. I have what I think I have and B. I'm using it the way it should be used. I'm not going to be stupid enough to risk my eyesight because I'm too stupid or too busy to take two seconds to read a fricken package. And for those that say well you are putting your contacts in first thing in the morning, do you not own a pair of glasses? Take two seconds and grab them to READ. If you choose not to, it's your fault not the companies. I don't have contacts and I know that Clear Care is my husband's cleaner that goes in his special case with the tablet and that it better bubble each night and that his saline (that he rinses them off with each morning BEFORE putting them in his eyes) is something completely different. I sure as heck wouldn't go in my closet and just grab any ole thing I find without reading and assume it's bug spray or sun tan lotion without checking it out first. Oh wait that was Raid. I'm going to sue the company because they should have known what I wanted and sounded an alarm! This country will never be the same for so many reasons, but on the top of the list is the fact that there is no accountability for anything. It gets worse with each generation.
I have used this product for years and they couldn't put anymore warnings on that thing than they already have. I have not had any problems with this product by simply reading the directions and following them but then again I am not an idiot like those that cannot see the numerous warnings or read the simple directions.
This is ridiculous! 'hunterbear' you hit the nail on the head!
People have to be stupid to put this in their eyes! I use this product, its wonderful, lens feel like new after they are cleaned. There are all kinds of BIG BOLD RED WARNINGS, including a cicrular cut out that is on the top of the bottle so if you hold it up to you eyes you see it. Perhaps the contact lens manufactures encourage an article like this due to the fact that this product can extend the life of disposable lenses????
I have used this for YEARS. The TIP of the bottle is RED and has been for years.
You can't fix operator through anything but training and experience. Experience the burning just once from forgetting to change the neutralizing disc will prevent you from EVER doing it again.
You can't fix stupid people through legislation. People need to be knowledgable about the product they are using.
I have been using this cleaner for years and it is wonderful!! I was informed from day 1 by my optometrist (who recommended it) that it had hydrogen peroxide and not to put it in my eyes. On occasion, I have accidentally rinsed my contact with it, but the burn was minor and after rinsing I had no issues (I just wore my glasses for the rest of the day). If people are going to the ER over this, it's because A) They don't know how to read, B) They poured it directly into their eyes. The solution includes the case!! The bottle has always indicated clearly not to use directly on eyes, use the case, and don't put your contacts in after rinsing with it. It's amazing how uncommon common sense is. I'm tired of protecting the idiots of the world. Survival of the fittest! And if people want to say that children are making the mistake; maybe they shouldn't be using the solution unattended or maybe they are too young and irresponsible to use contacts. Parents: blame yourselves, not the product. We cannot childproof the world!
Wow...Americans are either phenomenally lazy or stupid or a really bad combination of both. I've used this product for years when I developed allergies to the preservatives in other contact lens solutions. When you get it, it says prominently on the box NOT to put it directly into your eyes. There is a cardboard collar around the top of the bottle that says the same thing and tells you to make sure you use their cases and leave the contacts in them for at least 6 hours. The tip of the bottle is bright red...just in case you forget.
Seriously....are people this stupid that the company is going to have to make a special tip which would only fit into their cases? This either indicates that Americans are officially too lazy for their own good, or it's a damning indictment of the US education system because they fail to emphasize the importance of reading even the box before using a product.
I've done it and I am not stupid or lazy. The bottles were too similar in appearance, and if you are in a rush, like I was, it can happen.
You are mistaken. Apparently, you are stupid or lazy.
yes you are. If you cant read instructions or are too lazy to follow clear directions, you are lazy, stupid.
All I'm saying is I have burned my eyes with this stuff on accident before. My brother and sister started using it and I ran out of contact solution one night and I grabbed theirs thinking nothing of it. No bueno. It's easy to make that mistake though unless you know better. They should just make it a little more obvious I think.
I have used this product when I came home at 3:00 A.M. stoned drunk and never had a problem.
I just can't wait for a bunch of IDIOTS to ruin this product for the rest of us. Read the label. Read it! For crying out loud, it says don't put it in your eye. So don't!
OMG! This happened with me about 2 years ago! I have been wearing contact lenses for years and have never mixed up the products. But Clear Care's bottles are too similar, and if you are in a rush, it can easily get confused. I have never screamed so loud and hard in my life! Had to go to the eye doctor immediately. I still use the product because it is the best disinfectant, but I'm extremely cautious now.
Well if you're "in a hurry" perhaps you should slow down and pay attention to what you are putting into YOUR EYES!
I have been using the product for years and I haven't had a problem. Yes I know it can sting sometimes if I don't rinse them good but I have read the label and I'm pretty sure my eye dr told me that as well. Seems like too many things we buy have side effects that someone wants to get a lawsuit out of!
I really don't think it's fair to refer to people who've mistakenly used this product in a traditional case as stupid. When folks use traditional products year after year after year after in a traditional way, they don't always read labels. Yes, EVEN when it's going into their eye. Frankly, once those contacts are out, I can't see a thing. My mishap occurred while traveling. I purchased the travel size of this product because I saw "NO RUB" on a box that was travel size. When packing, I removed the bottle from the box and placed it in a pint sized ziploc along with my other liquids and tossed the box. I swear to God, there was no cardboard thing on top of the bottle. I swear. The next day after spending close 20 hours traveling, well after Midnight, I got to my hotel room and removed my contacts, placing them into a traditional soaker. The only kind of soaker I even knew existed. About seven hours later, I awoke and immediately reached my right lens. After the screaming and crying ended, I spent the next 24 hours with cold compresses, advil, and eventually a pad and patch to soak up drainage and hide the light. It was HORRIBLE. The next night, I awoke with such a horrible feaver. I grabbed the bottle, thinking WTF is in this crap! That's when I saw the 800 number. I called it and of course the very first thing you hear before anything else: flush forever and proceed directly to the ER. It was then that I thought to myself, how on earth did I miss all this? Personally, I believe it's because I was traveling with a man and two small children for a long weekend all the way across the country, but I really don't know that if I'd been at home in solitude, would I have caught it. After getting home, I found the "goofy" container in the box in the wastebasket. To wrap this up, about six months later, my best friend told me about this product that has "changed her life" as far as contacts go. I decided to give it a try. Purchased it again. Full size. THIS time, it had the cardboard warning and I saw the red tip. I have been using the product non-stop for a couple months now. My contacts are 100% more clearer and less irritating. So, on one hand, it's a horrible safety hazard. On the other, it's life changing. That's my story. I even have a picture. Yikes, am I pathetic looking... I felt as if I had acid in my eye. Horrible, horrible horrible.
excuses, excuses. Do you need a label on stairs saying "CAUTION, STEP!).
Read the label. Your mom cant follow you everywhere.
My first experience with Clear Care was when travelling as well. I actually forgot my regular solution at home and the only thing I could find at the gas station was Clear Care in travel size - but even it came with a special case. Without even reading the label I made the correct assumptiont that I should use the case that came with the solution. Then, the next moring when I was rested, I read the label. That was the cleanest my contacts ever felt and I have not gone back to my old solution since.
I have worn soft contacts for 32 years and have found Clear Care to be the absolute best cleaning method I have ever used. Years ago, when you used a heater and pure saline solution to clean contacts, you could buy salt tablets and distilled water to make your own saline for about $20 for a whole year's supply! However, due to stupid people not following directions and getting eye infections, we now need to buy special pre-mixed solutions that end up costing about $150 for a year's supply! As we see now, these same idiots will still find ways to hurt themselves no matter what you do ! I just hope this great product doesn't get pulled from the market because of a few morons!
lol so true!
OMG!! Exactly how flipping stupid are people? I've used this product for years and have never had any problems. For heaven's sake, the tip of the bottle, under the cap, is RED!! A clear indication that perhaps you should not put said product directly in your eyes!!!
Because more men and women (air quotes included) cant be a grown up and handle sh*t themselves. Pathetic.
"Clear Care Cleanser" - try saying that 5 times fast!
The complaints are mostly from morons that dont know how to follow instructions and want everyone else to take the blame becasue they cant even step off a curb without suing someone. Or (2), this is from the illegal immigrants that cant read English (although just about everyhting is in Spanish). Pathetic. Put on your big boy pants and stop whining when the idiot in the room is you and you cant follow instructions and need to blame someone else for your failure to be a grown ass grown up.
I have used this product for years and there are clear warnings everywhere. I have also witnessed people in my own home, grab whatever bottle they see that says "contact" on it and use it like they know what they are doing. Some people just do not read labels or listen to people telling them to be careful and then they blame someone else. Please do not make them change the bottle because of stupid people. It will make it more expensive and this does not need a prescription because people will continue to be stupid.
Please stop the insanity!
I have used this product for years. The warnings are clear. It is the best product for cleaning yours lens and preventing infection. In over 25 years of contact lens use, I have never had an infection or problem with my eyes. Optometrists will tell you it is the best product available. Multi purpose lens cleaners/storage solutions just don't work as well. Each box comes with a new case. The people who say their eyes have burned after storing lens for six hours are likely using a old case that needed replacement as the platinum discs do not work forever. I just hope this product continues to be available because I am positive it has prevented many more eye problems than it has caused as a result of users who cannot read the label.
do you need you mom to follow you everywhere to tell you to READ LABELS????
I use this product. If you can't read a label on a container, then you shouldn't be using it.
I have used this solution for around 5 years, and yes it can burn your eyes. But the bottle clearly states warnings and the tip is even red! Anyone who is buying something to put in their eyes or on their contacts should be reading the bottle. I can only use a peroxide system due to massive allergies and have no complaints about this solution! It is fantastic and if people use common sense they should not have any issues. Reminds me of the woman suing McDonalds for having hot coffee. Of course coffee is served hot. Who in the world puts a flexible styrofoam cup in their crotch?! Use your head!!
First of all I've been wearing contacts every day for 12 years with always the tradition saline solution, so the one day I ran out of solution and grabbed my brothers without looking was the first time I had ever learned this product existed, totally thought it was just regular solution. Quite a rude introduction I might add. They should just make the red label part bigger or something because I would guesstimate that most contact wearers still use the traditional saline solution mostly and it's easy to make this mistake. If you buy the product for yourself and don't read the directions you're a moron. If you mistakenly think it's something else because the bottles look exactly the same and the warning is tiny and hard to see without your contacts in, that's a problem the company should address. Just make it look different from saline solution because it is not saline solution.
You can't fix stupid!