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Subscribe to RSSNearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.
CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company's Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.
The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.
Dozens of Avaira Toric users reported problems ranging from hazy vision and pain to severe injuries, including torn corneas, which required emergency medical treatment. Company officials were accused of issuing a "stealth recall" in August that left many consumers unaware of the problem.
Company officials noted that no product lines other than Avaira Toric and Avaira Sphere use silicone oil to manufacture the products. The firm expects to set aside a reserve of $9 million for the costs of the expanded recall. All told, the company expects to spend $23.2 million on the Avaira recalls, according to the press release.
Consumers with problems or questions related to the recalls should contact the company at 1-855-526-6737. The firm says it has reached out to affected consumers to ensure their safety.
Related:
Torn corneas, vision problems follow 'stealth' recall of contact lenses
Under pressure, contact lens maker acknowledges reports of pain
CooperVision, FDA step up public warning about recalled contact lenses
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I used to wear Avaira contacts and stopped last year due to blurry vision and eye pain. I thought I just had a "sensitivity" to wearing contacts. I have NEVER been contacted about a recall. My prescription would have still kept me in those lenses through this year! Still no word on a recall!!! Thank you, MSN
Hopefully you've had your eyes checked for any possible damage. I would imagine they will be fielding plenty of lawsuits.
LOOK...LOOK with you blinded eyes!!
These lenses were big sellers with the box stores--Costco, Walmart, etc. Ya get what you pay for.
"MOE, MOE - I CAN'T SEE, I CAN'T SEE!!
"WHAT'S THE MATTER STUPID"
"I GOT MY EYES' SHUT, nyuk, nyuk, nuyk."
Sad to see-
Such irresponsibility.
"Stealth Recall"?? You know what that means? We will tell Walmart and COSTCO to pull the product, but not the general public who may have already bought it and are putting it into their eyes. See corporations have no problem self regulating and will always do the right thing.......for their fellow corporations. They are more concerned with trying to protect walmart and COSTCO than their actual customers. Dang! There goes that stock price... poor shareholders. The good news is that I am sure it will not effect this years executive bonuses.
Cooper vision contacts were the only disposable ones I could find that weren't painful or blurry. Fortunately, I'm on different ones that the avaira. I just hope this won't destroy the company. You can also get acuvue, bausch and lombe, etc. contacts at costco and walmarts so getting them from either place has nothing to do with it. It is sad about the recall, but most offices are calling the patients who received these and letting them know.
There are recalls all of the time. Companies and products we've grown up with and are still in business today, such as Tylenol, Benedryl, General Mills, Pepreridge Farms, Novartis Pharma, Insight Pharma and Nestle, to name a recent few, now have Coopervision joining them. www.fda.gov/safety/recalls will provide additional insight. Angry-villagers-with-torches is a knee-jerk reaction - I'd recommend calling the company to find out more, ask questions and make your decision after you get the facts.
My sister put Avaira contacts in the eyes of her TWO YEAR OLD! Apparently she got some great deal (she loves Costco) and thought her daughter would look better with blue eyes than with brown. Well, I guess she learned her lesson - Her daughter is now 11 and she STILL CAN'T READ! They literally have to draw comic book style pictures of how to use the microwave, how much food to give the cat, etc. when they leave her at home. It is a shame. Well, I am glad to hear about this much needed recall. I hope she gets a refund or something!!
omg. Sorry, it is your sister who was wrong. She doesn't need a refund, she needs a new brain. How anyone could think of putting contacts on a 2-year-old's eyes is beyond me.
Avaira contact lenses have only been out for a few years, and they also don't change your eye color, so maybe you're thinking of a different kind?
During the period when I wore those contacts I'd felt like total hell. Not only did my eyes get blurry, I felt like I had a nasty flu. It stopped when I stopped wearing them, but now my eyelid is swollen and "wrong" looking. They're having everyone send back in their contact lenses for replacement, but I feel like it's because they're getting back as much evidence of a very dangerous product as they can to prevent lawsuit. I'm surprised more people haven't come out with this, but,as with me, I never suspected my contact lenses as causing major illness. When I went to the optometrist, he claimed nothing beyond blurry and uncomfortable eyes could result because of those lenses, however the eyes are made up of soft tissue and if you have an allergic reaction to a residue on the contacts that wasn't properly removed, I would think that could cause major problems. I'm not even sure what I could do to have them tested, however one thing I know is that I'm keeping them in case I need them as proof for corporate neglect
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