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Subscribe to RSSNearly two months after problems were first announced, contact lens giant CooperVision Inc. and federal health regulators have amped up public warnings about nearly 780,000 recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.
The federal Food and Drug Administration on Friday posted a Class I recall warning about CooperVision's Avaira Toric contact lenses, which were first recalled Aug. 19 because of residue left behind during manufacturing. In a safety alert, the FDA identified the substance as a silicone oil residue.
Class I recalls are the most serious kind of recall and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
“If your lenses have been recalled, immediately remove your existing lenses, discontinue lens wear and return your lenses to your eye care practitioner or point of purchase,” CooperVision officials wrote in a statement posted Friday on the FDA's website.
Consumers have reported problems with hazy vision, discomfort, severe pain and eye injuries requiring medical treatment, the release said.
The notice comes after FDA officials demanded that the Fairport, N.Y., firm broaden its notification of the recall of Avaira Toric lenses manufactured from Nov. 1, 2010 to Aug. 3. The FDA now says some 778,301 lenses were distributed. CooperVision officials originally said about 600,000 lenses were affected.
FDA officials had threatened to issue independent notice of concerns about the contact lenses if CooperVision didn’t adequately publicize the potential for problems caused by unidentified and unintended residue left behind during manufacturing.
"CooperVision's public communications are consistent with the agency's expectations for a Class I recall," Morgan Liscinsky, an FDA spokeswoman, said in an e-mail Friday."The FDA will continue to monitor this recall's effectiveness to ensure that the affected devices are moved from the marketplace and not used by consumers."
CooperVision had issued what Phyllis Entis, author of the blog eFoodAlert, called a “stealth recall” of the products in the United States after issuing more detailed recalls in several other countries, including Australia, Hong Kong and Spain. Entis first raised concerns in August, when she started receiving reports of serious eye injuries tied to the Avaira Toric lenses.
"In my opinion, CooperVision is engaging in damage control, now that their problem is no longer stealthy," Entis said.
The early release said that consumers experienced only hazy vision and discomfort.
Since then, Entis said dozens of consumers have reported problems ranging from blurry vision and eye irritation to corneal abrasions and tears that required emergency department visits. Some reports involved CooperVision brands other than Avaira Toric, but FDA officials said no other brands have been recalled.
Most of the users said they were not notified by the retailers who sold the products, including Costco, Walmart and LensCrafters about the recall. Nor were they told about the potential for injuries by their eye care providers. Some consumers said they intend to sue CooperVision for financial and medical harm blamed on the recalled lenses.
FDA officials had received at least 15 reports of injuries related to the recalled lenses, including severe injuries such as corneal tears, said Liscinsky, the FDA spokeswoman.
Consumers can check to see if their contact lenses are affected by the recall at www.coopervision.com/recall. Or they can call a toll-free consumer hotline at 1-855-526-6737 for more information.
Related:
Torn corneas, vision problems follow 'stealth recall' of contact lenses
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CooperVision, are you serious? From the CooperVision website: "small number of unexpected wearer reports of hazy vision and discomfort"...My son has been complaining of blurry vision and headaches. After changing to new pairs over and over he quit wearing them this past week and blurred vision and headaches have subsided. A residue 'leftover' on lenses that are in packaging CLEARLY marked sterile!! The first recall was Aug 19th? Where did you post the recall CooperVision? Is the recall on a post-it sticker in file 13? Obviously you care more about money and prestige than you do the consumers of your product. We will return every single one to our eye care provider and will insist on any company other than yours!!!
This brings to mind the Alpo dog food approach to marketing "distractions". It's the idea that Alpo refused to acknowledge the illnesses and deaths of so many precious dogs that makes me cringe to see their product on store shelves. An injured consumer never forgets.
I recently bought 2 boxes of CooperVision Toric contacts, not listed in the recall. Immediately had scratched corneas. Took out the contacts to see tears. So I wore my glasses for a few days, wrote it off to bad luck, and opened a new pair a few days later. Result: SAME. This time I checked them prior to putting them in my eyes. Small tears in the contacts. I put them back in their package and opened a third. SAME DEAL. Too much coincidence for my liking. Went back to America's Best and they apologized for the inconvenience and re-ordered my usual brand at no cost to me. This was my first time using CV Toric's since the woman said it was the same as my usual brand just a few dollars a box cheaper and I was looking at cost cutting measures for my budget. I learned my lesson. They need to broaden their recall. Their manufacturing is shoddy at best. Luckily I have glasses and took mine out, but I know far too many contact lens wearers who do not own glasses and will wear their lenses no matter the pain and discomfort.
They don't.
Re comment about conservative panic. Hardly. Remember, us older folk went through Viet Nam, SDS, Chicago Weathermen, Hippies, Woodstock, Kent State, SDS and on and on. Most are in the corporate world these days, except for some of the older professional protesters looking to rekindle past glory. Actually their effort is a bit pathetic.
Been there... done that.
This Occupy thing is more like a wannabe movement and is nothing compared to the 60s. The 60s folks had a legitimate complaint about the Viet Nam war. The draft was a big motivator.
What do the Occupiers have....? basically a whine about jobs. Jobs come and go. At least you aren't being forced to become cannon fodder like the 60s generation was.
The 20s and 30s had their depression and dust bowl, the 40s hard WWII, the 50s had the Korean War, the 60s and early 70s had Vietnam. The country has had it pretty good for 30 to 40 years and just recently have hit an economic soft patch. People are spoiled. That is not worth creating a movement over.
The Occupy folks, should occupy their time finding a way to help the U.S. economy get going again through creative enterprise. Today's conditions are an opportunity...
Opps,
The computer burped and moved me over to the wrong article. Am reposting to the correct article.
You get what you pay for. Crappy lenses=crappy vision.