FDA ‘Aware’ of CooperVision Contact Lens Recall

More than one month after CooperVision’s recall of “specific lots” of Avaira Toric contact lenses, most people in the USA still are unaware of the recall.

Consumers in Hong Kong, Australia and Canada have been alerted to the problem with these contact lenses – by the Hong Kong Department of Health, the Australia Therapeutic Goods Administration, and Costco Canada, respectively. Health Canada has said nothing. Nor has FDA.

The reason given by CooperVision for the recall was the receipt of “…a small number of unexpected wearer reports of hazy vision and discomfort.”

Readers of eFoodAlert tell a different story – corneal abrasions, severe eye pain, ER visits, eye infection, and facial swelling. I have reposted their comments and reports at the foot of this article.

According to reader reports, the recalled CooperVision Avaira Toric lenses were sold directly by eye doctors, as well as at Wal-Mart, LensCrafters, Costco, and over the internet through 1800CONTACTS. None of these US suppliers have posted a recall notice for the benefit of their customers.

But never fear! FDA is on the job.

An email request to FDA for information on this recall drew the following response today (September 22nd) from Morgan Liscinsky, in FDA’s Office of Public Affairs:

“As a follow up to your email, the FDA is aware of this recall and is gathering information as quickly as possible. The FDA’s Center for Devices and Radiological Health will continue to monitor the situation and will work with the firm to assure that the recall is handled appropriately and that consumers are adequately notified.”

This FDA comment comes more than one month after the recall was “announced” by the manufacturer of the lenses.

My request to CooperVision for a comment on their recall has not been answered.

This recall has received no press coverage worth mentioning – not surprising, considering the low-key tone of CooperVision’s original recall notice and FDA’s silence. I repeat my call to eFoodAlert readers to help publicize this recall by doing the following:

  1. If you or a family member wears Toric contact lenses, go to the CooperVision recall web page and enter the lot number of your package to determine whether your lenses have been recalled. If you no longer have the package, and you have experienced any discomfort whatsoever, stop wearing the contact lenses. Contact your optometrist or ophthalmologist for advice.
  2. Email this story to any friends or family members who wear contact lenses – especially if you know that they use Toric lenses.
  3. If you, a friend, or a family member has experienced a problem with these lenses, please post your story as a comment, below. Please state where you live (city, state/province, country), and where you purchased the Toric lenses. I’ll add this information to the recall distribution list.

Following is a complete and consolidated list of the fourteen (unedited) injury and illness reports I have received as of today, September 22, 2011.

From Helen on August 27, 2011: My son went to ER due to severe eye pain. His 1st Avaira Toric caused blur vision and rainbow coloring to his vision, but it disappeared couple days later. Then his 2nd pair had the same effect. so he took them off. Then his eye pain started. It was so intense we took him to ER.

From Krystal on August 29, 2011: We are located in Texas in the US and my son was in severe eye pain he had to miss the 2nd day of school. This was a horrifying experience for my family. The pain inflicted on my son was unbearable to watch. After taking him to his doctor then to an ophthalmologist purchasing 3 different prescriptions the bills staked up. His cornea was severely scratched and swollen. A week later he is doing better. We are just praying no long term damage was caused.

From Dan on August 29, 2011: My daughter also had to go to the ER due to severe eye pain after using these contacts. Diagnosed with severe tear to the cornea. Doing better now, scheduled to follow up with an opthamologist today. Contacts were purchased at the walmart in Hampton, VA.

From Ineke on August 29, 2011: I purchased contacts at Costco in Seattle WA and also ended up in the ER with the most excruciating eye pain. ER doc noted that the corneal abrasion was in the shape of the contact lens.Has anyone inquired about reimbursement for medical bills? I incurred several hundred dollars due to the ER visit as well as follow up eye care and lens fitting.

From Holly on August 30, 2011: I purchased the contacts at Costco in Irvine, CA. I also ended up in the emergency room due to severe eye pain and swollen face. I was diagnosed with corneal swelling and a severe corneal abrasion.

From Scott on August 30, 2011: I received a call at work around 2:15 am and it was my wife crying and telling me her eyes hurt and she could not see! I took her to the ER and she was diagnosed with corneal abrasion. These new contact lenses are supposed to be so great… Better vision is what they – Cooper Vision states on their adds, that is a joke. We are going to seek legal remedies on this company!!! And I think this is going to blow up more, that this is only the beginning of complaints.

From Angela on August 31, 2011: I experienced blurred vision in one eye after putting on a fresh pair of Aviara Toric contacts. It was severe clouded vision that lasted for about 2 hours after taking the lenses out. I talked with my optometrist and my eye appeared to be normal, but he thought their could have been a scratch on the eye.

From Annette on September 1, 2011: I purchased the Avaira Toric lenses in Spring, TX through 1800CONTACTS. When I took them out on the first day of wearing them (Tuesday, 8/30/11) it felt like I scratched my eye. When I woke up the next morning I couldn’t open my eyes. The pain was so severe. I went to my eye doctor and was told that both my cornea’s were torn. She gave me a prescription for an antibiotic but I still can’t see well enough to drive. I have never felt pain like this before.

From Mellisa on September 5, 2011: REGARDING AVAIRA TORIC CONTACT LENSE: I’ve suffered a severe corneal abrasion due to this lense. My lot number is involved in the recall. Over the weekend I noticed vision in my right eye was filmy so I removed the contact. About an hour later I was in severe pain in that eye–felt like a bee stiniging my eye. Doctor at the ER said I had a corneal abrasion in the shape of a contact over 15% of my cornea. I called my eye care provider and they said they had no idea of the recall. It’s frustrating that no one from either company failed to notify me that these lenses were defective. I live in Atlanta, Georgia and purchased these lense at a Lencrafters.

From Dee Angela on September 8, 2011: I experienced SEVERE eye pain. It hurt to have my eyes open it hurt to close them. It felt like something was scratching my eye. I have experienced this twice. I was in bed all day. I was going to go to the ER but I decided to take something to put me to sleep.

From Lorna on September 10, 2011: After wearing Bousch and Lomb for years, I went to Costco to get a new prescription of contact lenses and they gave me a pair of these contacts to try… at first I thought that I had picked up an eye infection because we had had been away at a funeral so I was constantly touching my eyes with tissue…when we got back home and my eyes cleared up they gave me a new trial pair but after a few days the same thing happened to my eyes, I am so frustrated because all they did was call me and tell me not to wear them, to throw them out and to come back in for another pair to try. After two weeks of eye drops the lady told me I dont need to use them any more and within a day of stopping the full infection and pain is back. I woke up this morning in pain, my eyes won’t stop watering and I look horrible.I am thinking I will never trust to wear contact lenses again. All I am offered is a new pair to try… I can’t believe that a company can be allowed to get away with this… all their key people should have to go through this themselves and maybe they will take our pain and frustration into account and run their business with some sort of integrity!

From Leslie on September 16, 2011: My son got these contacts as his first time trying contact lenses. He is 12. I am shocked at the thought that these lenses could have harmed my childs vision. He wore the trial pair with out any problems, but when we opened the new box he had problems with the right eye being blurry & sore. We cleaned the lenses overnight & tried them again the next day. We threw away that pair & tried another pair. Still the same. They were blurry & hurt. The right lens did not hurt. We then tried 2 left lenses because his Rx was almost the same in both eyes. That worked. I told the vision center where we purchased them about the problem & they reordered the contacts fo us thinking there was a problem. My son continued to wear the 2 left lenses. He then told me they were itching & bothered his eyes & refused to wear them. Yesterday I found out they have been recalled. I called my eye care provider & they ordered new trials & told him not to wear them again. We purchase the lenses at Wal-Mart in Elkhart Indiana. This was an eyeopeining experience for me.

From Deirdre on September 18, 2011: I too went to the emergency room in July 2011 – severe pain that i cannot describe – I also was treated for a corneal abrasion and sent home with 3 different prescriptions and oxicodine for the Pain!! I am utterly speachless that my eye doctor did not warn me of the recall – I even went to my doctor’s office 3 seperate times complaining of my left eye. I am appalled at the lack of communication and want to know what exactly the “residue” is?

From Deirdre (again) on September 18, 2011: I want to know exactly what this “residue” is and plan on taking legal action. I also went to the er with severe pain in my left eye. This pain was worse than child birth. I too had a severe corneal abrasion. I went to my eye doctor THREE TIMES complaining of my left eye. Why didn’t they know about the recall????? This is pure negligence. I bought my lenses in Bryn Mawr Pennsylvania from my eye doctor.

From Diana on September 22, 2011: I scratched my cornea twice because of these lenses! It was the worst pain I have ever felt and I am still paying off the ER bills. I am furious that these lenses were the cause. My eye doctor called me about the recall, claiming it was due to the contacts causing “dryness” and said they would be replacing my lenses with another type at no charge. This was after the first corneal abraision, which I just assumed was my fault- that I took out the lens improperty, which is what the ER doc said is usually the cause of these abraisions. But I have been wearing contacts for years and this had never happened before. I did not tell the doctor about the abraision, because they only asked if I was experiencing any issues related to my contacts being dry or uncomfortable. Then I had the second abraision this past weekend and thought maybe the recall had something to do with what’s happening to me. So I looked online and found this website and immediately called my eye doctor. The nurse on the phone brushed off my concerns, saying that the lenses were recalled only because they caused dryness. I just went to pick up the replacement lenses and I took a print out of all of these complaints to my doctor. The nurse told me that “You can find anything on the internet” and again said these contacts only cause dryness. Then she gave the print out back to me without even looking at it. I am furious and am switching eye doctors! If they had been upfront with me from the beginning, I wouldn’t have scratched my cornea a second time! And what the heck is this residue? It’s all very scary because I feel like we’re being lied to!

13 thoughts on “FDA ‘Aware’ of CooperVision Contact Lens Recall

  1. I started wearing Coopervision contact lenses 4 months ago upon my opticians advice and I have found them comfortable and easy to manage ever since. I didn’t realise there was a recal on some of their products, I was lucky enough not to have experienced the faulty batch, but have the greatest of sympathy with those who have experienced any sort of pain. Found the eye health advice on the Vision express website really beneficial in the past for any contact lenses related issues I’ve had, might be of some help.

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  2. I purchased a year supply of avaira toric lenses in august 2011 I had problems since day one with them When I first put them on they are ok for a short time; then they become blurry and they make my eye hurt i have to take them out and i cant try to wear them for at least 3 days it causes me to have mucus build up in my eyes i complained to my eye doctor and she prescribed proclear toric but they did the same thing to me My eye doctor has written me off as a complainner She actually acted annoyed with me because I said neither lens works for me I went thru a year supply in two months I called my eye doctor to let her know about recall and was told they we’re recalled due to not being able to keep up with the dfemand (orders) I said if that was the case they would be back orders not RECALLED They dont recall contacts because they cant keep up with demand She said she has not recedived any information about the recall I emailed consumer care at cooper vision no reply I called the number supplied by cooper vision to call weith concerns about the recall I was told can not help me with out the lot numbers I dont have the lot numbers They took my name and number and said they will have someone call me back Still waiting for their call

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  3. I have worn CooperVision Clear Soft lenses for a while with no problem, –but over the summer, I began experiencing pain , redness, itching, and a strange gummy discharge in both eyes from time to time—-and had NO IDEA about the recall until tonight.

    Some of the lenses were fine, and others, I had to throw out.–I attributed it all to allergies, and just kept using Visine for relief.

    Tonight, the situation became suddenly severe, and I went on line to see if there was anything written about this–and I am shocked and furious at the negligence of Cooper, the FDA, and my practioner– Cohen’s Fashion Optical in NYC for their silence.

    Just now, I entered my lot # on the Cooper website–and the response was that my lenses were not affected(??!!)

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  4. 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.

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  5. I had the exact same problem with 2 different boxes of CooperVision Frequency55 toric lenses, both from the same lot #3698000705. The first box was bought in April, and after going through half the pack and having the same problem each time I put in a new lens (hazy vision that remained even after taking the lens out and discomfort) I requested a replacement for those lenses. The replacement lenses were fine. I just popped in a new contact from the refill box I received over the weekend and was revisited by the same problem. I stupidly decided to “deal with it” until I got home from work and by that time the pain was unbearable and my vision remained blurred after removing the lens. I went to the ER and the doctor said my cornea has abrasions all over the surface. I am still in pain and hope this doesnt happen to anyone else!

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  6. A friend of mine told me to check on recalls with contacts since I have been suffering with problems since the first week in July. It started when I went for an eye exam and got fitted for new lenses. I was given a new pair and that’s when my troubles began. I had itchy eyes, some burning pain, swollen eyelids and discharge. I have been treated twice with antibiotics and my eyes clear. Then treated as allergies. Every time I put in a new pair I am back to the same problems. Now I am on steroid drops because my eyelid inflammation and itching won’t go away. I have not worn lenses in a month. I can’t believe non of my doctors thought of this. I have spent so much on doctors visits and medications. I am going to tell my doctor tomorrow and contact the company. I can’t believe I have been suffering for months over this. I wear Ultra Flex toric lenses and I bought them the first week of August.

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    1. Like you, Christina, I also wear ULTRA FLEX toric lenses, which I purchased from a Costco in Fountain Valley, CA. I suspected it was just my eyes were getting tired and enflamed from wearing my contacts for too long, but now that I’ve read the many posts regarding Cooper Vision’s toric lenses in general, I feel it necessary to report the problems of eye irritation I’ve been experiencing to Cooper Vision.

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  7. I have had redness, constant tearing, swelling, pain , itching and blured vision in my left eye for a couple weeks now since I put in a new pair of contacts. I keep taking my contacts out after a couple of hours of wearing them because they hurt my eyes. At first I thought maybe it was allergies but then the whole area around my eye became tender to the touch and my boyfriend pointed out that the symptoms are only in my left eye. I thought it might be an issue with my contact since that’s when it started so I just looked online and found out about this recall on Avaira Toric. I plan on calling the doctor tomorrow. Also I would like to mention that since I got this order of contacts there have been 3 that I have thrown out because they had visible blurry spots on them that would not come off no matter how much I washed them.

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  8. I started wearing Coopervision contact lenses 4 months ago upon my opticians advice and I have found them comfortable and easy to manage ever since. I didn’t realise there was a recal on some of their products, I was lucky enough not to have experienced the faulty batch, but have the greatest of sympathy with those who have experienced any sort of pain. Found a health advice on the Vision express website really beneficial in the past for any contact lenses related issues I’ve had, might be of some help.

    Like

  9. CooperVision initiated a voluntary recall of certain Lots of Avaira Toric. While we do not actively monitor or participate in online blogs, we were informed of this one and felt important to provide more details which can be found at CooperVision.com. We ask Avaira Toric lens wearers to call our Consumer Customer Service Department to learn more, ask any questions and allow us to help, 1-855-5-COOPER, (1-855-526-6737) or email consumercare@coopervision.com. (Consumer Care hours of operation are 9:00AM – 5:00PM ET Mon-Fri).

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