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Subscribe to RSSAmid growing reports of eye problems ranging from blurry vision to torn corneas, federal health officials are threatening to issue a public warning about recalled contact lenses manufactured by CooperVision Inc. and sold widely at stores such as Costco, Wal-Mart and LensCrafters.
The Fairport, N.Y., firm has yet to heed a request from the federal Food and Drug Administration to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August because of unidentified “residue.” On Tuesday, CooperVision officials said the recall affected about 600,000 contact lenses, or 10 percent of those sold or issued as samples in the United States.
“Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses,” FDA spokeswoman Morgan Liscinsky said in an e-mail.
But for at least a dozen consumers who indicated to msnbc.com they have suffered impaired vision, excruciating pain or landed in emergency rooms after wearing the contacts launched in April and recalled in August, such notice is long overdue.
“It is very frustrating that they’re not more vocal about it and that the FDA hasn’t warned more people,” said Mellisa Cotton, 40, of Atlanta, who said she suffered two corneal abrasions this summer after wearing Avaira Toric contact lenses.
“Next to labor, a corneal abrasion is one of the most painful things you can have," said the mother of two.
Dan O’Neil, 0, of Hampton, Va., said his 15-year-old daughter, Erin, had to be rushed to the local ER on Aug. 21 after using Avaira Toric contact lenses from a newly opened box from Wal-Mart.
"I noticed what first looked like a torn piece of contact on her eye," he said. "Upon closer examination, I realized that what I was seeing was Erin's cornea torn and rolled back."
Doctors confirmed a severe tear and the girl was treated with pain medication and antibiotics. Only after she was injured did O'Neil and his wife learn of the recall.
"The ophthalmologist didn't even seem to be aware of it," he said, adding later. “Any time your kid’s vision is affected, you’re going to worry.”
CooperVision Inc. officials issued a voluntary U.S. recall on Aug. 19 of what the company called “a limited number of lots” in the U.S. market. On Aug. 25, the company notified the FDA of the recall, officials said.
CooperVision officials said they initiated the recall after investigating a “small number of unexpected wearer reports of hazy vision and discomfort.”
A notice posted on the company’s website includes a fill-in box where customers can check to see if their lots are affected. However, it does not include a list of retailers or a complete list of affected lots.
Major retailers said they notified their customers quickly about the Avaira Toric recall. About 2,600 Costco customers who bought the lenses were notified on or soon after Aug. 19, said Craig Wilson, vice president for food safety and quality assurance. Wal-Mart notified its optical departments on Aug. 24, said spokeswoman Dianna Gee. A LensCrafters spokeswoman who didn’t want to give her name said the company notified customers immediately through its retail stores.
Those moves, however, followed wider international notification of the defective lenses, including recalls issued in Hong Kong, Australia and in Spain, where the public notice included a list of more than 200 affected lots of lenses. The Hong Kong notice indicates that Avaira Toric lenses were also recalled in Canada, Germany, and Italy.
But the company has yet to issue wider notification in the U.S. that the FDA has the authority to seek, but not demand. “We are requesting that the firm issue a broader statement to ensure that users are aware of the recall,” Liscinsky, the FDA spokeswoman, wrote in an e-mail.
CooperVision officials, did not respond to msnbc.com questions about why they had not complied with the FDA request. In a statement, a firm spokeswoman said that the company “has fully cooperated with the FDA and continues to closely monitor the situation and seek advice from FDA during this process." The company's stock, traded as COO, fell on Tuesday.
Critics say that CooperVision has downplayed the recall of hundreds of lots of contact lenses in the United States, exposing vulnerable consumers to ongoing injury.
Phyllis Entis, author of the blog eFoodAlert, which tracks public safety recalls, has been following the Avaira Toric situation since August, documenting what she said “can only be described as a stealth recall.”
The blog includes reports from several consumers who have reported injuries and other problems with Avaira Toric contact lenses from August through October.
They include Deirdre Shapiro, 43, of Villanova, Pa., who said she suffered hazy vision and a scratched cornea that "felt like someone was in there with a sharp instrument stabbing my eye."
She wore the contacts for months, until September, when her doctor finally notified her of the recall.
"Literally, my whole summer, I thought I was going crazy," she said. "I wish I'd known. I would never have put this thing near my eye."
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Ah yes, the wonders of more free trade agreements with counties that have NO REAL STANDARDS when it comes to things like contact lens. These people should sue congress for their ignorance and arrogance over the health of the people. Instead they look out for cooperation who have the biggest lobbyists kissing butt and giving big donations in campaign funds.
For your information, the recalled lenses were manufactured in England.
ANOTHER USEFUL IDIOT...Looks like jogree is another young skull of mush, taught to hate america but not having the correct info to shoot off the mouth....no standards?? crawl back under your rock.
The question is why the FDA has allowed this to drag on. Once the company failed to make the wider recall announcement the FDA should have stepped in and done it for them. The FDA should not be giving these companies multiple chance to comply while more and more people are being injured. If this is the way the FDA is going to react, then there is really no point in having an FDA. The FDA either needs to start doing it's job PROMPTLY or just go away and be replaced by an organization that will.
Major fail for the FDA, but it happens every week. Note that the FDA can only request notification - cannot order it. That is thanks to laws passed by the largest collection of sold-out corporate whores on the planet: the US Congress, both parties..
Yep, that's what we need. Less regulations of corporations. The Republicans have it right. Let the corporations regulate themselves. So far we have torn corneas and biotoxic corn. And that's WITH regulation. It'll be so much better without it.
And let's not forget the Listeria outbreak. After the Republicans slash the food inspector's budget.
The Republicans are truly VISIONARY.
Why is the FDA involved. Just because peoples eyes are falling out? Let the free market work. When enough people are blinded then they won't buy that brand anymore. Simple economics!
No, we don't need regulation is this country. All our businesses are SO honest and NOT greedy at all.
Wake up America!
(banging fists on table)
Free market!! Free Market!! Free Market!!
( I dont see what could go wrong )
Reasonable regulations are needed. Unreasonable regulations that serve no useful purpose other than to stifle the growth of an industry are not needed. Please learn to tell the difference and then teach our Federal Government to do so.
Problem is when people like Michelle Bachmann suggest on completely shutting down agencies. We do need a balanced approach. Unfortunately that's not what Republicans seem to want.
We have plenty of regulations and this still happened. Let them pay through the nose through the judicial system. Lots of money will soon change hands.
Ernie, the problem is that industry will rail against any and all regulation, regardless of whether it is onerous or completely legitimate and beneficial. Until politicians are no longer beholden to corporate interests the consumer is at risk.
On that note, I vote that no interest group or anyone contributing moneys, time, effort to any political activity be permitted to hide behind laws that let them operate without exposing their funding, etc. (Not so) SuperPaks, etc. should all be required to fully expose all sourcing of funding and any politician voting for any legislation which directly affects themselves (taxes for the rich, etc.) be required to abstain.
Think Darrell Issa, and all the other rich in congress will go for it? Of course, this affects both left and right so I'm sure there will be bipartisan support for not doing it.
nah - they will follow regulation, but rather just pass the cost along to the consumer so they can continue sticking it to us and making a HUGE profit. Banks are the biggest offenders, but medical comes in a close second - I mean $250 for a tablet of tylenol? Seriously....I'd say no walk out the front door of the hospital across the street to the CVS, buy a bottle of the same exact thing for $6 and be done with it. You'd think hospitals and pharmacuticals are being run by the same people that ran the military and thought nothing of a $800 toilet seat
Ernie-201266-
Why don't YOU teach our government, Ernie? You seem to be the man for the job.
@ Sick of the Right's Crap: I propose all congressional members be required to wear NASCAR type overalls with the badges of all their corporate sponsors plastered all over them. In fact, I'm surprised there's not a website like that where you can search for congress men/women by name and up they pop in their badge-wear. I wish I were more creative.
In the 1920's the "Free Market" had child labor, people working 16 hours in smoky factories around open machinery and exposed drive belts, and puny wages with no retirement, health insurance or worker benefits.
Marilyn, I LOVE IT! Maybe have them get tattoos on their faces. Make it harder to disown their sellout.
I'm not excusing the manufacturer for making shoddy crap, but... I think if I were sticking a contact lens in my eye, and it felt like someone was stabbing my eye... for months... I would have TAKEN IT OUT long before the doctor had to tell me take it out and not kept it in ALL SUMMER LONG. Shoddy manufacturing is one thing, but not taking steps to protect yourself in the wake of obvious pain and danger seems a bit silly. I'm just sayin'.
You mean the coffee is hot and I might burn myself? Clearly the lack of logic dictates behavior.
@ Dave,
lol, I thought the same thing. How dense is this woman not to realize it was the lense? Months?
Having worn contacts for years, it's pretty obvious when you get a defective lense.
I didn't understand that one either. Normally you wear contacts for a few hours a day until you are up to the time your Eye doctor has told you to wear them. Also my eye doctor told me when I started to wear them, (many years ago now) that if they hurt at all to remove them, clean them, make sure they are turned the right way and then try again, if the pain persists, toss that pair and try another, if there is still pain, take them out, put on my glasses and call him.
However, I do think this recall should be made more public and just put out there.
Alex D - Regarding the coffee comment, you might enjoy watching "Hot Coffee", HBO's documentary about the real story (not McDonald's lobbyists' propaganda) behind the hot coffee incident. It is truly an eye opener.
Yes, it is, eedo17. Everyone thinks they know the hot coffee lawsuit story and they don't know a danged thing about it, all they know is (as you posted) the propaganda put out there by McDonald's. Of course, I'm sure all of those misguided people are Reps. :)
I talked with a lawyer familiar with the case a few years ago. While the woman was partly at fault, the McDonalds was also partly at fault. The whole story is not exactly common knowledge. The burns suffered by her were very severe, due to the excess temp of the coffee, which that McDonalds had been warned about, repeatedly.
It is sick that these dangerous contact lenses are out there, that the FDA knows about it, and that they have said NOTHING until now. The FDA is just a shill for the medical industry.
This just proves the point people have been trying to make for a long time, corporations run government, not the people you elect to office.
This is why the people that are protesting on Wall Street and other major cities need to move there front to either specific corporate buildings or right to the Federal Government. They are protesting the people that run the show and have no motivation to change their ways because change was already done in their favor.
Stop supporting the rich the easiest way we know how, don't purchase their products until they get out of Washington. The consumer has the ability to make change in any product purchased off a store shelf or online. Pick a major corporation that spends too much in Washington or that took their operations over seas and stop buying it. We have this great tool to communicate with the masses all we need to do is find a way to make it work in our favor.
Just imagine what would happen if we all decided not to buy a certain brand of product, all at once. Even more effective if the product has an expiration date. We could shut a company down in a matter of six months. Once this power is shown then we can go to the FDA and other government agencies and tell them to get back to doing the jobs we elected them to do.
Why are we wasting federal money funding an organization like the FDA when they don't have any teeth to do anything but "recommend" to a company that they do anything about their defective and life-threatening products and foods?
We're right back to where we were with the wipes that killed babies. The FDA "recommended" the company recall the wipes... the company ignored the "recommendation".... it wasn't until it became front page news that the FDA pushed for the company to really do anything, and even then the word was that the company didn't really have to do what the FDA "recommended" and could fight them in court.
Either give the FDA power to do something to safeguard the public when they have proof of danger, or disband the fricking organization and let the news organizations do what they do best... throw it in the headlines and force the companies to own up... and let the lawyers have at them.
FDA = USELESS!
The FDA, like the EPA, OSHA and many other agencies, is useless because they've been downsized, muzzled, and hobbled by the "Free Marketeers" and anti-regulators. They do not have the staff nor the funding to do much more than "recommend", and any punitive action they can take seems to be taken by the guilty corporations as part of the cost of doing business.
Who needs regulation? Companies will regulate themselves. Oh, and the FDA isn't being bought by anyone....
Most contact lenses sold here in the U.S. are manufactured overseas. The same holds true for pharmacueticals.
That's why I don't wear CooperVision toric lenses anymore and haven't for several years. I have Johnson & Johnson Acuvue Oasys lens and couldn't be happier. Just wish my astigmatism would make up its mind and stick to ONE rx and quit jumping back and forth, not to mention quit making them so damn expensive!!
Be lucky that you don't live in Texas. The court there ruled that the manufacturer was not liable (and the individual had to pay CooperVision $1.3M in legal fees). The court ruling was that the individual had 2 eyes and both were not injured - therefore they could still see and no injury occurred.
Another win for tort reform. Thanks to Gov Perry and his cronies.
Tort reform is great for corporations. You can't sue them, but they can still sue YOU.
"Next to labor, a corneal abrasion is one of the most painful things you can have." Really lady? I think that's a stretch. No pun intended.
Ever had one?
Alejandro - you clearly have never had your cornea torn. I can speak from first hand experience - it is the most painful experience that I have dealt with. It was worse than a large Kidney Stone (done that) and much worse than getting stitches without painkillers (done that in a combat situation).
If you don't know about a topic - you should practice the old adage (modified for the internet): Be silent and let people think you a fool, rather than post and remove all doubt.
I know I'm tired when I read Torn Corneas and my brain turned it into Corn Tortillas. And yes I'm wearing my glasses.
Nevermind...posted in wrong place.
The important thing now is to prevent people from filing those class action suits that are wasting so much money.
Stealth eye ball cornea recalls, what is that like military fighter jets or something? Glad my best friend is okay after the same surgery last year ago, so far so good.
This reminds me of the FDA's and producer's approach with the tainted wipes:
Drip. Drip. Drip.
To the FDA: What is it, exactly, that makes you move with alacrity? Is it a certain number of people that are hurt or who die? Could you share, so that the rest of us know what the threshold is?
To the executives at CooperVision: I hope you get your eyeballs sued outta you.
They should be sued till they go blind.
sedgwickgrad--wouldn't it be interesting to know the number of ambulance chasers that are drooling all over their ties. I'm an optometrist and I can't believe these numbskulls were wearing these lenses and not removing them when they started to hurt.
A lot of times when patients report pain, the optometrist or doctor just says its in their head, or they tell them to just tough it out.
gene047-- I had this happen to me after wearing these contacts-- I had no pain at all until after I took them out at night. The entire day my brand new contacts had been rubbing a layer off of my eye, but the natural lubricant under my contacts prevented the raw part of the eye from coming in contact with air or anything else (so I couldn't feel it). The next morning my eyes were swollen shut and I couldn't open them. I felt like someone was stabbing my eye with needles. If the other cases were anything like mine, they probably didn't feel pain until after taking the lenses out.
Imagine what will happen if the GOP has its way with what it describes as overly burdensome regulation? You'll have millions of people seriously injured by unsafe products. Of course, the wealthiest 2% will continue to do just fine since they will be able to afford higher priced thoroughly tested products.
Toothless regulations that we have misplaced confidence in are nearly as bad as no regulation.
My first wife had radial karatomy surgery in the 80's. The eye surgeon did one eye and a few months later, the second. Before surgery she had to sign a contract saying she released him from any present or future lawsuits. Within 20 years she was legally blind from it. Be careful fooling with mother nature.
Torics are unpleasant to wear in any case. They're shaped like donuts so they don't really sit well on the cornea, and they're thick, which reduces oxygen to the cornea.
I will stick with glasses, I'd rather be a nerd than a blind cool guy.
This recall has nothing to do with Congress, you moron.
Well, actually it kinda does. Congress has reduced funding to regulatory agency, including the FDA, and has rewritten or eliminated many regulations that actually give the FDA the authority to require companies to do anything.
Many of these idiots railing against private industry and corporations are very likely contact lens wearers that wear their lenses beyond the recommended replacement schedule, don't clean and disinfect them properly and then want to sue for their own damned stupidity. You get exactly what you deserve when you don't follow wear and care instructions and get problems with your eye. Thats YOUR fault, not the manufacturer.
Everyone is commenting and complaining mostly about the government here... what about the company Cooper Vision. Isn't it their responsibility and morality that is in question here? As a mother of a son this happened to, I am pissed beyond belief that they could ruin my sons eyes and just go on as business as usual not. Not to mention the cost, time and pain of several doctors and eye clinics we have been to. He put his contact in, by the time he got to work he was calling the eye doctor and in and hour he was at the doctor, not days. We found this was something that happened over time of wearing them and messed up his corneas (not I put a bad lens in one day). Your vision is your life, put yourself in our shoes if it was your eyes that are now messed up. The government did not do this to his eyes Cooper Vision did!!! If there is a class action suit against them I would like to know about it or start one...
I agree, this is so frustrating to me. The argument always turns to why the Feds didn't catch them. Like its their fault it happened. The anti-government types do this all the time. When will the companies and corporations, who think of everyway possible to cut corners and increase profits, be held accountable for their actions? Only when their caught. If their not caught, blame the Feds. How twisted is this logic? Lets not forget to cut their budgets to the bone and make their job even harder. Companies apparently only have responsibility to make profits, any way possible. Morality has nothing to do with it.
Damn! I wear reading glasses and I was considering getting a bunch of different colored contact lenses. Forget it, I'll stick with the glasses.