CooperVision is resisting a request from FDA to broaden its notification of contact lens problems, according to an article by JoNel Aleccia of msnbc.com.
The company issued a news release on August 19, 2011 to announce the recall of Avaira® Toric contact lenses, which was initiated due to “…the unintended presence of a residue on certain lenses,” and posted a recall page on the CooperVision website.
Although CooperVision claims to have notified retailers – including Costco, Walmart, and LensCrafters, among others – not a single Avaira® Toric retailer in the US appears to have posted the recall notice on its website. Only Costco Canada has posted such a notice – advising its customers that Encore100 Toric contact lenses (a CooperVision brand) were recalled.
Since the August recall announcement, I have received injury reports from more than twenty eFoodAlert readers. The latest reports, which were posted only this morning, describe problems with Frequency 55 Toric lenses – also a CooperVision brand:
From Carol in Pennsylvania – I live in Pennsylvania and purchased Frequency 55 Toric lenses from 1-800-contacts. This was in August/september 2010. I had hazy vision in one of my eyes, and ended up in the emergency room with a corneal abrasion. I also experienced about a month later the same issue in my other eye. Why isn’t Cooper Vision recalling Frequency 55 lenses as well. They have the exact same issue.
From Brian C. (no location) – I had the exact same issue with my left eye and Frequency 55 Toric lens that just happens to be made by CooperVision. I have not seen any mention of this brand in any media. I suffered a swollen eye, discharge, excruciating pain in my eye. I was given drops to clear the issue. This happened 2 months in a row. My doctor looked at me like I was crazy when I said that something is wrong with the lens. It happened the first day of the month for 2 months straight when I changed my contacts. It began with a cloudy spot in my vision in the morning and then an escalating amount of discomfort through the day and finally by the end of the day I could barely keep my eye open. Unfortunately, I didn’t have a spare lens case around or my glasses when I was at work.
FDA certainly thinks that the recall notification was inadequate. Morgan Liscinsky of the FDA Office of Public Affairs, informed me by email today that the agency believes a public recall notification is called for.
“As it stands,” Liscinsky stated, “the FDA believes that public notification of this recall is needed and has been in discussions with CooperVision regarding a firm-issued press release. Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses.”
Liscinsky added that “…as part of its recall processes, the FDA regularly investigates whether affected devices should be added to an ongoing recall. When the FDA identifies such devices, it works with the devices’ manufacturers and distributors on appropriate recall strategies.”
FDA has the authority under the Code of Federal Regulations to mandate a recall of medical devices – including contact lenses – but only under specific circumstances and after following several time-consuming procedural steps. In practice, the mandatory recall process is too cumbersome to be used, except in extreme cases.
It’s time for FDA to “independently share its concerns” and issue a Consumer Alert about Coopervision’s Toric contact lenses.
eFoodAlert 
I stopped wearing the 55s last June, but my eyes still have discharge and daily contacts bearly get me thru the day… After one year, I would say it is permanent.
Instead of Coopervision being proactive and recalling the Aspheric 55s, they don’t seem to mind more people damaging their own eyes. Everybody should report/return some the defective products to the company, file a complaint with the FDA but hold on to some evidence as well. A class action lawsuit wouldnt do a thing since these corporation’s have no soul, but public knowledge of defective products aka lower stock price will wake up the execs!
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I wear Frequency 55 toric lenses in the left eye, and Frequency 55 aspheric lenses in the right. I used to have no trouble with either of them, but that changed after my latest box of torics from Lot 3686001014. As I have been going through this box, each month I notice that several hours after putting in a new lens, the vision in my left eye will get cloudy like it is covered in film. This never happens in the right eye. Using rewetting drops or rinsing with cleaning solution does nothing to help. It usually clears up after a couple of days of just living with it, but it is extremely annoying before then. I finally looked it up online because it was bothering me so much, and it just didn’t seem right. New lenses should be at their clearest, not their cloudiest. I found this website, and now I am a very concerned. I’m remembering other experiences earlier in the the year that I did not think were related. A couple months ago, I thought I must have gotten a grain of facial scrub stuck in my eye and scratched my cornea, because it felt so gritty when I took the contact out. Last month, I thought I needed to change my brand of storage solution because my eyes were stinging so badly when I first put the lenses in. Now, I am under the impression that I have had a very close call. I am going to ask my doctor about switching away from CooperVision. There is definitely something wrong with the Frequency 55 torics lenses, not just the Avaira lenses. This needs to be better publicized.
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I have been wearing the Coopervision Frequency 55 Aspheric lenses for over a year. This new shipment of contacts that I have recently ordered has me going to the emergency room. For the past few weeks, I thought I picked up pink eye since my friend had it. After wearing glasses and using the drops, everything seemed fine. After wearing the contacts for a couple days, it kept coming back. Now I have a serious abrasion in the shape of my contact lens on one of my eyes.
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I tried on a new pair of Frequency 55 yesterday after not wearing them for about a year. about an hour later My vision really started to get foggy in my right eye. I continued to leave them in hoping it would clear up. I finally decided to take them out after the fogginess was getting worse. My vision continued to be foggy even with them out and lasted for a couple of hours. It really freaked me out and was ready to go the ER. I tried to get a refund for the lenses from the retailer but was stone walled as there is no official recall on this product. i live in Canada and was wondering if anyone knows whom to contact to lodge a complaint in hopes they recall this product as they have other of their toric lenses in the past.
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I just discovered that I have a cornea abrasion and I believe it was caused by my contacts- Coopervision Frequency 55 Toric. I put a new pair in and instantly my right eye was blurry. It got progressively worse during the day and when I took it out to rinse and put it back in the pain was unbearable. After a few hours I couldn’t even open my eye. I was diagnosed with a cornea abrasion. I believe this issue only occured in my right eye becasue the left eye has a different contact lens type and is not the Coopervision Frequency 55 Toric.
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I found this post when researching the recall of Coopervision’s contacts- mine are the Frequency 55 toric. Last evening I was able to get in to see my eye doctor after experiencing haziness, swelling, itchiness, redness and pain in both eyes after inserting a new pair of lens that I recently purchased from 1-800-contacts. The haziness began a half-hour after inserting them, which has happened every time I put them in but then clears up eventually. After taking the contacts out because the haziness got worse instead of better, that’s when my eyes became very swollen, very painful and irritated and STILL hazy! My doctor of course told me my eyes were very irritated and my corneas were enlarged. Also, I should note that when I opened ONE new contact container (I have the same prescription for both eyes) there were TWO contacts inside! I used the two instead of throwing out the one… It seems there should be a recall on these too, no? I have been using them for a year and have loved how comfortable they are as my eyes are very sensitive. I will not be using them and will contact 1-800-contacts to inform them of the problem I have. Today, the haze is gone, but my eyes still ache and are still very swollen.
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I have the same issue but mine was easier to determine. Wearing frequency 55 toric for 2 years and just had 2 new boxes drop shipped from discount contact lenses.com. Done I had an uneven number and I had just changed my right lens I only changed the left. Within 5 minutes my left eye began to look like it was cloudy. I took the lens out and cleaned it and put it back in. I hoped it would resolve itself, and it bothered me all day. I took the lens out and my vision was still cloudy, but resolved itself by the morning. I put the same lens back in the next morning and boom same cloudy vision. Took that lens out and cleaned it and waited for symptoms to resolve. Then I put in the next lens from the pack and boom, cloudy vision. Cleaned it very well and put the lens back in and it began to be unbearable a few hours later. Since removed the lenses and the symptoms resolved themselves. Only found out about the recall (which was not for this specific lens) but refined my search and found this site. I am very upset.
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I had problems with Frequency 55 too. They were good for two weeks then it would get cloudy and move around. I’ve had discharge even after removing them. I assumed it was pollen in the air. Every contact would go bad after 2 or 3 weeks. I would use rewetting drops constantly.
Ed from New York City
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I just started to use the Frequency 55 toric lenses and have been experiencing pain and redness in both of my eyes, I decided to stopped wearing them just this morning because my left eye hurt so bad as soon as I put it on, coincidentally my husband heard about the recall for the Avaira lenses. I called the company and they said that they have not had any report on the Frequency 55 Toric lenses. they suggested I call the place where I bought them.
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I keep watching & waiting for Coopervision to expand the recall here in the US. I wear Coopervision Proclear contacts and have been out of my contacts for 2 1/2 weeks. My doctor describes the damage as “pits” in my eyes and says it is from dry eyes. But I find it curious that my problems only started after purchasing 2 new boxes in August. (from my doctor’s office) I have never had dry eyes before. My contacts were made in the UK, but the lot numbers on the box were not listed on their website. When will we find out what the residue is and how much damage it will/can cause?
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I heard the ending of the news report on the radio this morn, regarding contact lens recall, so I came home to look it up. My husband of 13 years has worn contacts all his life, had a corneal transplant in his right eye and knows what eye pain is….. had me take him to the emergency room last Sun. for his good eye, woke up feeling fine, two hours later blurry vision, eye started getting red, he was then in agony, we were there for seven hours, he kept asking them for numbing drops….they could only put them in so many times w/out causing blindness, he was then given 2 injections over the course of the time we were there for pain. The dr said it appeared a layer of his cornea was gone and there were ulcers on it. He was sent home with three different medicated drops and pain meds. Over the course of the week had to see two specialists, and basically stay in bed with his eyes closed other than me driving him to the dr due to the pain of opening his eyes. He still can’t put contacts back in. Not one of the specialists mentioned a recall, his contacts are made by coopervion but are not the toric lenses.
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Thank you for your work on this! Very much appreciated.
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You’re very welcome, Aaron.
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