E-mail updates
Follow on Twitter
Subscribe to RSS
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.”
Related stories on Vitals:
Leave a Comment:
The warnings are very clear, plus the tip is RED, meaning "DON'T PUT THIS IN YOUR EYE!" However, it's still possible to burn your eyes and not be a moron.
The instructions state that the product is neutralized after about 6 hours. After 9 hours, figuring it was safe (and after using this product for years with no problem), it still burned my eyes to the point that they were swollen and very painful. I did NOT rush to the emergency room, though.
The case does need to be changed periodically, as the disk that neutralizes the hydrogen peroxide only has so many uses.
It was brand new, but thanks for the tip.
You probably overfilled the case, and there was residue of un-neutralized solution around the cap. Again, can be solved by following the directions.
Thanks for pointing out the error of my ways! I have been using this stuff for years, and have read the directions, but I appreciate your helpfulness in pointing out some imagined user error. Sometimes stuff just doesn't work the way it's supposed to.
Read people read! Yes, the RED nozzle should tell you something too. I have to admit, I once did squirt it on my contact lense and put it in my eye thinking it had grabbed the saline. It wasn't because I didn't know I wasn't suppossed too, I was in a hurry grabbed, squirted and inserted...LOL. Yes, it does hurt but that was my own stupidity, I'll admit that not blame them for inadequate labeling.
Evidently step one should read "1. Remove head from ass before use." Read the friggin instructions and stop blaming everyone else for your own stupidity! In my opinion, this is the best contact lens care system on the market.
Best comment yet. You literally made me lol.
you have got to be kidding my whole famil uses this contact cleaner. It is clearly marked to NOT put directly in the eye and to use the case that comes with it and to soa for min of 6 hours. Why do we have to hold the hands of people who CHOOSE not to follow(read ) the directions. Yes they have a choice if this product is to difficult for them to follow the directions they should use the regular saline solution orgo back to wearing glassed.... we do not need to hold teir hands.....its a choice no one forced them to use it.
LOL, when are we going to take responsibility for our actions........
Love Clear Care, just have to pay attention to what you are doing.
Idiots.
The bottle has a bright red tip, the box and solution bottle is covered in warnings, the top of the solution bottle has a bright red cardboard collar around the neck of the bottle that contains a warning, and the box comes with a full set of instructions. How anyone can screw this up is beyond me! My 13 year old daughter has used this solution for almost a year without one speck of problems... apparently she's smarter than your average contact lens wearer!
If you can't read or comprehend simple instructions, maybe you shouldn't buy a product that is more complicated that your brain can comprehend. Just sayin'.
Well, I used it for 14 years before I made a mistake. You ever had a bad day, been a little absent minded? Bet you could've used someone attacking your integrity and intelligence as you just have. Human error happens and mistakes happen. The point is that one mistake with this can have life long consequences. I used a different container to put my lenses in about 10 hours later put them in and have severe burns all over my eyes. I didn't know that is you didn't use their exact case that is what would happen. I just thought they wanted you to buy their case like most companies want people to buy their crap specifically. Thank you for telling me I am a moron though. I'm an engineer, was top of my class, and went to the top school. I think at this point in my life I've learned how to follow instructions pretty well. I hope your daughter shows more compassion and understanding to strangers than you do. It's people like you that have made the world such a hateful and misunderstanding place. Also, I hope her eye doesn't dry out one day and in her blurry haze she accidentally grabs the wrong bottle. My mother always told me not to say anything I didn't have the nerve to say infront of anyone-anyone, at any time. I wish I could see you in person to dare you to say any of your rude, disrespectful, and ignorant BS to my face.
"I'm an engineer, was top of my class, and went to the top school."
If that was true, you wouldn't have problems reading directions and following recommendations. Believe it or not, it actually says in the instructions WHY you need to use their case. You sound like a litigation happy apologist.
"I wish I could see you in person to dare you to say any of your rude, disrespectful, and ignorant BS to my face."
Yet another internet tough guy. You talk about people being hateful and "misunderstanding" yet you follow with an implied threat. Hypocritical much? Please, please, please don't ever breed.
You people are stupid, who say it's not clear enough.I use this and it is in Bold Red lettering all over the damn place.It's all over the bottle do not rinse lens then put in eye..People need to go back to school and become literate..Just people trying to sue probably and make some money..Poor bastards..Payback is a bitch if thats what they are trying to do
I've used this product and others like it for over 30 years. I made the mistake once of mixing up the bottles, back before the red cap and warning were on it. Yup, it hurts. Yup, people do it all the time. My eye doctor said he's never had a patient do it twice nor anyone end up with permanent damage. If we label everything as hazardous, no one will pay attention to the REAL hazards!
Wow, I've been using Clear Care for years and years and love it!
If you're too stupid to notice the warnings on the box, the bottle and the bright red lid on the bottle I imagine contact solution is going to be one of the LEAST dangerous things you're going to injure yourself with.
People may make mistakes, but if you spill bleach on yourself or burn yourself with a match you don't complain about the manufacturer do you?
In other news -
"Skin burns linked to misuse of lighters"
"Accidental hand amputations linked to misuse of saws"
"Pulmonary aspiration linked to inhaling while drinking water"
"Tongue and mouth cuts linked to eating food off of sharp knives"
again we must pay for the stupidity of people. READ<<<<< before you use. my family has used this product and others like it for many years. without going to the homes hour much more of a warning can you put on the bottle. People take responsibility for your own actions......
I, too, have been using this for years and never had a problem. I'd hate to have to get a prescription for this product. People really need to read instructions. And if they aren't capable of that, then perhaps they're not capable of doing what it takes to wear contact lenses. Perhaps they also don't wash their hands well before handling, inserting or removing their contact lenses and expose themselves to potential infections. If you wear contact lenses, then you must turn your brain on when dealing with them or have the mental capacity to do so. If not, then don't use contact lenses. But don't make the rest of us responsible users have to pay for your mistakes.
I switched to this product from the multipurpose solution at the recommendation of my opthalmologist. I'm willing to do anything to ensure that my eyes are safe and can tolerate contact lenses for as many years as possible. That's my reply to the comment above, "Unless this product has advantages that put it light years ahead of others, I don't see the point of exposing people to the risk that one moment's inattention will produce a chemical burn in the eye." I'm a responsible user of the product. The way I am a responsible driver and a responsible drinker. People make mistakes while driving and, unfortunately, while drinking. Does that mean we've banned cars and alcohol? People will continue to make mistakes, but unfortunately, that's how the world functions. Don't make others pay for your mistakes or "moment's inattention".
As for putting our contacts in first thing in the morning when we're half asleep, then we need to find solutions to that instead of potentially taking the product off the market or making it - heaven forbid - a prescription product (which wouldn't stop people from making the mistake, either, by the way). For example, wear your glasses to make your coffee and wait until the coffee has had its effect to put in your contact lenses. And/or, in the evening, when you put your contacts to soak in the solution and the special case, then put the bottle inside a medicine cabinet or something and only have your saline solution/rewetting drops on the bathroom counter, so that even if you're sleepy, the only bottle available when you reach for it is the bottle with the harmless liquid in it.
Excellent common sense advice...unfortunately it seems many of the complaining users have little to no common sense. It's a sad state of affairs when companies have to stupid proof their products.
As with most eye cleaning products or even dilating drops, this product should have a red cap and a red dropper tip. Manufacturers are forgetting the fact that if a patient wears contacts it's because they can't see well without them.......
So if you can't read what you're putting in your eyes you just go ahead and put it in there anyway? Did you ever think maybe to get someone to read it to you then? Come on, take responsibility for yourself and your own actions. The red warning band and tip should have told you something. Personal responsibility, something you might want to look into.
It does have a bright red tip, and a bright red warning band on the label.
BAD PRODUCT!!!!!!!! I quit using it! After several "burn" episodes. I only hope that my left eye (I always put the first contact in the left) is not permanently damaged but I fear it is.
Very good product. Too bad you never learned to follow the instructions. Don't blame the product/company for your failure to read and follow the instructions. Personal responsibility, something you might want to look into.
You've never made a mistake MrEd? I've worked as an eye care professional for over 30 years and have seen hundreds of ways people can make mistakes. It's not hard to do. Making a modification to packaging to help people use their product is properly is good business. And may even save someone's eyesight.
doobrd
sure Ive made mistakes, and I take responsibility for them myself. I don't blame the manufacturer for my failure to use the product as intended. The product is labeled and packaged quite sufficiently, red nozzle, red band on the label, red warning on the box, directions for proper use including warnings on what NOT to do. So what do they do now? Do they need to design a bottle that will not allow the user to get the bottle within ten feet of their eyes? If someone is too stupid to read the label/warnings, etc what should they do? Should they require the product to come with a personal consultant in the box? If you get in a hurry and don't pay attention to what you are putting into your eyes, NO amount of warnings or packaging changes will suffice. There is a little thing called personal responsibility that more people need to learn, and "eye care professionals"(if you really are one) such as yourself only reinforce that lack by blaming the manufacturer rather than the end user who doesn't take the time to learn what they are putting into their own eyes. Anyone who puts something into their eyes without making sure of what it is and how to use it properly is responsible for the results, and deservedly so. I have an idea, as an eye care professional, why don't you make sure to instruct your patients on the proper usage of any products they might actually be using? But then most people in your profession seem to think that their time is too valuable to waste on their patients questions, most that I have met will just hand you a bottle of something and say "here, try this" and send you on your way. Add to that most people are too intimidated to actually make their health care professionals take the time to actually listen and answer their questions and you get people with no idea what they are taking/using but do it just because the "doctor" said too. The manufacturer is not responsible for the stupidity of the end-user.
It's not the product that's bad, it's your ability to READ AND FOLLOW directions that's bad. You read the article, so I'm guessing your literate, so what's your excuse for failing to read the directions and follow them?
I can't believe this is even a news story. I've been using it for years because I kept getting eye infections my freshman year of college and Clear Care is AMAZING when to comes to cleaning my contacts. I'm sorry, I just don't understand how you can miss the warnings on the box, the bottle, the cardboard around the tip, the red safety plastic around the cap, and the red tip itself. I hate how personal responsiblity and accountability goes out the window every time someone in this country does something stupid. If Clear Care goes behind the counter than so should everything else like Tylenol because you can OD if you don't read the dosing instructions, Afrin because it burns even when used correctly and it's not supposed to be used for more than 3 days...which people don't know unless you read the bottle, regular hydrogen peroxide because that's the main ingredient in Clear Care, and I could go on and on and on with everything found in a Pharmacy.
Dumbest "news" story I ever read.
...but Cohen said patients to continue to report accidentally putting...
Nice piece of journalism/proofreading there.
I'm glad to see most of the comments agree only stupid users are going to burn their eye with this. What kind of person would put anything into their eye without properly reading the label first? Idiots, of course. I've been using Ciba products with the neutralizer since 1985 and I've never had a problem. The label is very clear and the bright Red tip of the bottle makes you very aware the product should not go directly into the eye. The person who wrote this article obvioiusly doesn't wear contact lenses.
It DOES have a red tip.
Good. I wasn't sure because I don't use the product, my grown son does. I wear RGP lenses and there have been plenty of times I was distracted and grabbed the wrong bottle. If it wasn't for the red cap I could have easily used the cleaner by mistake. It's all too easy to grab the wrong bottle though and people do need to know that, especially since the labeling is so similar to the other product. Maybe the mfg could change the shape of the bottle.....anything to make it as different as possible.
Prime example of people will not or cannot follow simple directions. I've used this for 20+ years and it works great. Used it last night in fact and will use it tonight.
Ummm, Hello? Bright red band right across the top that clearly states to use the proper lens case and failure to follow instructions can result in injury! How much more are they supposed to do? Are they supposed to come with a company representative in the box to instruct you with each usage? People, read the label! Who in their right mind puts anything in their eyes without making sure they know what it is and how to use it? Idiots that's who! You can't legislate intelligence, idiots will always be idiots. If you are too stupid to follow instructions then you deserve what you get.
I wear contacts and don't use this product, but I do extensively read the info for every contact lens product I buy to find out exactly what to do with it. Besides not bothering to take the time to read the packaging, the only other thing I can think of is that these people can't read the packaging b/c they don't have their contacts in! Not the company's fault.
Why is it that someone else is always responsible for a dumb mistake? This is why we have warnings on lawn mowers to not use as a hedge trimmer. I mean really people.
I've been using this product for about 15 years. It's perfectly clear to me to NOT put it directly onto my lenses or into my eyes. There's an obvious red band around the top of the bottle with warnings and the tip of the bottle is also red. I think the usage instructions are completely adequate and that users are not fully reading the instructions. It's all about taking responsibility for one's own actions. These are YOUR eyes, people!
People are so dumb. Even if you choose not to read the directions, I would think the big red banner, pour spout and cardboard thing would at least make you wonder how to use it.
I've been using this product for the past couple of years because the other cleaner I was using just wasn't getting my contacts clean. My eye doctor recommended I switch to Clear Care and warned me not to flush my eyes out with it and to make sure to let it sit in the special case while it cleans for 6 hours, otherwise I could burn my corneas. I think about that every time I put my contacts in the case at night and can't understand why some people don't read warning labels first. They are all over this product! On the box and on the bottle several times!