June 6, 2012 at 8:17 AM ET
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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Copyright 2013 Thomson Reuters.