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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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On several occasions I have had the misfortune of experiencing the mind numbing pain that comes with inserting a non-neutralized contact lens in my eye, not because I didn't know how to follow instructions, but because the special case did not work. There is no way of knowing whether or not the case has stopped working, or in some cases is defective from the first use until you are putting in your lenses. It's like playing Russian roulette with your eyes.
There needs to be either greater quality control with the cases, or even a color tab that shows neutralization has completed (they do it with chemicals all the time), to alert a user whether it's safe to put the lens in your eye.
How fortunate for you, rottie to never have a problem. More all caps and exclamation marks for YOU!!!!!!
They put brand new cases in every box of solution. How do you know if the case doesn't work? If the solution does not bubble, the case is not working!
It is amazing that you say you follow the directions, but "on several occasions" you say you have burned your eyes. Gotta call BS on this one....
when you put the lens in the case and add the solution... it bubbles... I have never heard of a case not working.
You too, probably overfilled the case and touched un-neutralized solution around the cap with your fingers when you inserted the lenses.
Again, just follow the instructions. Fill to the line, not over it. Or use another rinsing solution before you insert your lenses. It's your fault, not the cases or manufacturer.
I have never had a case "stop working" that doesnt make sense to me. The case is just a case. It is the hydrogen peroxide that does the cleaning. The special case is to hold the lenses up so the bubbles can move past.....
First, the bottle has a RED tip with warning not to put solution directly in eyes printed at top near spout. Second, if you rinse the lenses off after they have soaked in the hydrogen peroxide solution, they do not burn. I teach people about the Clear Care system and I always remind them to rinse with sterile saline solution BEFORE inserting them back in their eyes. I thought that was just common sense, but apparently not.
Lazy people will blame anyone for there ignorance. This world just wants to sue someone for something so they do not have to work. WARNING...Do not put things in your eyes, ears or throat without risking injury....How stupid is stupid?
Just some more consumers trying to get rich off of being stupid.
There is always this question: "yes they can read, BUT do they understand what they read?"
Two very different things: So yes the companies need to almost put pictures on the labels for some people who CAN read, but don't understand WHAT they read.
I am a user of this product as well, have been for years, and have NEVER been dumb enough to put this directly in my eyes. How stupid have people become that they don't READ THE DIRECTIONS on products before they use them, and then after using them in a manner they were not intended, decide they want to sue the maker of that product.
What has happened to personal accountability in this day and age? PAY ATTENTION!!!
Clear Care is the best stuff on the market.... Seriously people, you are putting something on your eyeball...stop...read the label...follow the directions...its really not that hard. If you are not capable of doing that you should probably not even be wearing contacts.
I have had contacts for over 30 years. My wife bought this stuff and had it in the bathroom. The bottle is the same shape, size, and color as multipurpose contact solutions. (save the red spout) I grabbed it rinsed contacts and stuck it in my eye. OMG not cool. my eyeball blistered burned for days. A simple change in the bottle design would help tell the difference between multipurpose contact solutions and a product that burns your eyeballs. (when I do not have my contacts in I do not see very well)
so your failure to pay attention is the manufacturer's fault?? Personal responsibility, look into it.
Motor oil and antifreeze come in the containers the same shape, size, and colour. Do you mix them up too? What about bleach and laundry detergent? Baking soda, baking powder, and salt?
People have become way too conditioned to grab, use, and complain rather than read first and learn.
Come on doesn't anyone read labels anymore? Besides the tip of the bottle is red instead of white like all saline containers I think the people having problems are just plain idiots!!!!!
I use this product faithfully and it is more than obvious that you should use caution. Not only do you have to peel off the plastic safety label before unscrewing the cap, but there is a BRIGHT RED dispensing tip that is located at the top of the bottle. You have to be mentally slow to not know that this could cause extreme pain and you may want to read the warning labels before using. Some people are just trying to make a quick buck by placing the blame on someone else for their own stupidity.
This is the best stuff out on the market. We as a society are too lazy/under-educated to use the product. Companies will have to dumb down everything they sell. We're really stupid.
How f'n stupid can people become?!? READ THE FU@KIN' LABEL IDIOTS!!!! This is the reason shampoo bottles have warnings that indicate "for external use only". Better yet...volcanoes don't have warning labels on them that say "Don't eat molten lava. May cause internal injuries." Go eat some lava stoopid!!
This is a great product! Warnings are on the bottle! Take responsibility for your own stupidity instead of blaming the manufacturer..
My sister's husband uses this brand because he has issues tolerating contacts for long periods of time and the eye doctor suggested this product, my sister on the other hand uses regular contact solution. While on a family vacation she discovered that she forgot her solution at home, so he offered to share his, filled the extra contact container he always brings, and placed her contacts in it for her. She never saw the bottle. We shared a cabin with them and I noticed the funky looking contact case and the bottle with the red tip on top of the bathroom counter. I asked him why it was different and he said that it was a special solution for his sensitive eyes because it cleaned better. I asked him why, and he said something about stronger enzymes. It was the first night of the vacation, between us with had 6 kids to put to bed after a long flight and quick dinner. We were all exhausted so l let his explanation be the last word on the subject. I regret it to this day, may be if I pressed on with more questions he would have pointed out such a crucial difference and my sister would have known not to rinse her contact with it before wearing it.
The next morning we heard her screaming in agony, we found him desperately trying to pour water into her eye all the while this poor woman still had the contact on her eyeball. It was a horrible scene, her children were screaming, ours were screaming, and still her agonizing screams were clear above them all. My husband and hers had to hold her arms down while I peeled the contact off her eye, which was already swollen and bloody red. My first instinct was throw the contact away and immediately wash my hands, still not knowing what really happened.
He assumed she knew exactly what the solution was and never bothered to tell her about all the warnings.
Upon reading the bottle, I thought that the instructions were very clear, and ugly enough for me not to even want to risk using it.
My sister never knew about the most dangerous differences as she has been using Opti-Free for many years and had no desire to change to his, and he never pointed our it in the past nor did he as he offered it as an alternative to hers.
At the hospital the doctor told her that he felt the warning labels were appropriate, but giving my brother in law a dirty look, sarcastically added that since he was not the first user to share the solution irresponsibly, may be the bottle needed an additional sharing warning for idiots like him. Happy Family vacation!
So they just used a product they were unfamiliar with without reading the instructions? Now, who's fault is this? Anyone who puts something in their eyes that they are unfamiliar with is asking for problems. And if they allow their kids to do the same then they are not only not too bright, they are not very good parents. NOT the manufacturer's fault your sister is lacking in the intelligence department.
I did not blame the manufacturer, no where do I even mention the manufacturer or lack of labeling or poor labeling. If you take the time to read the post well enough, even the doctor blamed my brother in law for being irresponsible. I even mentioned that the doctor thought the labeling was appropriate.
It was simply an example of how people get burned WITHOUT being the manufacture's fault but instead someone's irresponsible decision.
Since I don't know you personally, I won't take the low road and throw any meaningless personal insults.
I once cut my wrist with a circular saw because I was using it in a manner for which it was not designed. My own stupidity cost me a trip to the hospital and 17 stitches. Should there have been a big warning label on it warning me NOT to be an idiot and try to use it like a mini table saw?? NO! Did I whine about how the saw was the problem? NO! Sometimes people do dumb things, this does not make it the product or company's fault. If you get hurt doing something stupid, accept responsibility for your own stupidity and move on. If you're not smart enough to read the BRIGHT RED WARNING on the box, label, bottle and instruction sheet then you are not smart enough to be on your own, get a caretaker and let them take care of you. Personal responsibility is something EVERYONE should learn.
I have been using this product for years do to an allergy with other solutions, never had any problems. If they are to STUPID to read the label and RED WARING on the very top of the label and bottle then too FREAKIN BAD! IDIOTS! Probally the same ones who order a steaming cup of hot coffee and dump it on themselves then want to sue.
There should be no reason to write this article and the patient safety group must be over cautious morons! There 3 very clear warning labels prominently displayed on the bottle! If you put it in your eye or didn't use Ciba's case your an idiot.
Grow up people if your are old enough to be putting contacts in your eyes you are old enough to read the label on the bottle. The cap is red that alone should get your attention. Also the disk is only good for one bottle of cleaner if you are not smart enough to change the disk for each and every bottle of cleaner your eyes are going to burn!!! We as people think that the rules don't apply to us well this one will get you every time and i don't feel sorry for any one that doesn't read the label
I have used this product for years without a problem. Why? Because I know how to read. If you don't bother to read the clearly displayed instructions, then you deserve what you get.
I am so sick of stupidity and people blaming theirs on others, or products or whatever. I think the red pour spout sends a huge message that this should NOT go into my eye!
I love the product, and if used by capable, competent individuals it works beautifully. How sad that this crap has to take up real news feeds. I suppose they also will need Mary Poppins to come assist them in putting their new solution whatever that may be in their cases and cleaning them as well! Come on people GROW THE HELL UP!
I have used the Ciba products for almost 20 years - first AoSept and now Clear Care - and have had no issues BECAUSE I ACTUALLY READ THE DIRECTIONS! This is the best contact cleaning product I have ever used and I find it ridiculous that lazy people who choose not to follow the clear directions and warning are causing them all this trouble. It's true that I have accidentally put the solution on my contacts instead of saline once, but you only do it once because the pain is intense. Then you kick yourself and get on with your life and pay more attention, not file complaints and try to sue people because you're an idiot. This is the reason that hair dryers have to put the "Don't use in the bath tub" stickers. Take some personal responsibility, people!
You would have to be a complete idiot to miss the warning already on the packaging.
You can't fix stupid! The bottle is clearly labeled, the bottle had a bright red tip and a coller around it that clearly states do not put it directly into your eye and only use it in the case that comes with it. Stupid people are going to continue to do stupid things regardless of how many warnings/labels/etc...that come with the product.
I use this product too! I made the mistake of NOT reading the instructions and painfully paid for that. I have since read the directions for Clear Care and every other product that I use. I learned my lesson. My fault - not the manufacturer!!!! It reminds me of the lady who sued McDonald's because the coffee was hot!!! DUH!
I wear soft contacts and had months of issues with itching contacts, replacements, ect. Then my Dr. recommended Clear Care and my eyes have been perfect,, I only had burning when I tried to "cheat" and wear after only 5 hours in solution. I did not know about the netural ring in container that wears out over time,, so I will change it more often, great product, I think some of the complaints are of accidental use due to not reading directions,, BUT I HIGHLY SUSPECT WE HAVE THE USUAL IDIOTS THAT WANT TO JUST SUE AND NOT WORK!!!!
PUT your contacts in and READ!
LOL!!!!!! I love this!!!!