“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 none 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.”

– comment posted October 2nd by Christina (in Florida)

So many people have reported their problems with CooperVision’s Avaira® Toric contact lenses to eFoodAlert that I have set up a Toric Recalls page tab. All posts relating to this problem – together with their associated comments – are listed on the Toric Recalls page.

The contact lens story began in August, when I encountered a recall notice posted by the Hong Kong Department of Health. According to the Hong Kong notice, the recall affected CooperVision Toric contact lenses in the USA, Canada, Hong Kong, Australia, Spain, Germany and Italy. So far, only Hong Kong, Australia, Spain and Italy’s health authorities have posted formal recall notices.

Neither the US Food and Drug Administration (FDA) nor Health Canada have alerted the public to the contact lens recall, although FDA has told me that the agency is monitoring the US situation. Nor – as far as I can tell – has Germany posted a recall notice.

When I read Christina’s comment (quoted above), I noticed that her contact lens brand – Ultra Flex – is not a CooperVision brand. It belongs to Ocular Sciences, Inc. (California). Ocular Sciences manufactures and markets contact lenses under a number of brand names, including: Biomedics, Hydrogenics60, EdgeIII, ProActive, SmartChoice, UltraFlex, Subsoft, Lunelle, Rythmic, and Hydron.

The Connection

The various brands of Toric lenses encompassed by the CooperVision recall were manufactured by CooperVision Manufacturing Ltd. (UK), located in Eastleigh, England. Likewise, one of Ocular Sciences manufacturing sites is in Eastleigh – right around the corner from CooperVision. And there is more.

John D. Fruth, the founder – and former Chairman – of Ocular Sciences Inc., was President of CooperVision’s contact lens division before he founded Ocular Sciences. And he served as a Director of The Cooper Companies (CooperVision’s corporate parent) from 2005 to March 2008.

It doesn’t take a major leap of deductive reasoning to suspect that CooperVision’s Eastleigh production facility may have manufactured Toric lenses for Ocular Sciences. If my suspicion is correct, the list of Toric brands that may be implicated in CooperVision’s “residue” contamination problem would include all of the following.

CooperVision Toric Lens brands: Avaira®, BioComfort XO, Encore 100, and Lent Soft 4 Air.

Ocular Sciences Toric Lens brands: AquaLens, Aqualite, Aquatech, Bioflex, Biomedix, Clearsoft, Clinasoft, Flextique, Hydroflex, Hydrovue, Mediflex, Natural Sight, Neoflex, Omniflex, Optiflex, Optiform, Polyflex, Polysoft, Procon, Proflex, Prosite, Sofmed, Softech, Softview, Target, UltraFlex, and Versaflex.

If you wear one of these brands of contact lenses and have experienced corneal abrasion, blurred vision, or any eye discomfort, please contact your eye doctor, report the problem, and refer him or her to the Toric Recalls page for more details.

More than one month after its initial recall notice, CooperVision has added more production lots to the list of recalled contact lenses.

Thanks to a recall notice posted by Spain’s Agency for Drugs and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, or AEMPS), we now know that the recalled lenses were manufactured in the United Kingdom by CooperVision Manufacturing Ltd.

Last month (August), we learned from the Hong Kong Department of Health that the recalled CooperVision contact lenses were sold in the USA, Canada, Hong Kong, Australia, Spain, Germany and Italy.

Brands affected by this recall include Avaira Toric (multiple countries), Lent Soft 4 Air Tórica (Spain), Encore 100 Toric (Costco Canada), and BioComfort XO Toric (Hong Kong). Following is a complete list of recalled lot numbers, as provided in the Spanish recall notices:

10509500015006, 10526500022008, 10442550000004, 10454500011010, 10471550002004, 10490500007016, 10510500012016, 10526500023006, 10443500004004, 10454500011018, 10471550002010, 10490500009008, 10515500012006, 10526500023014, 10444500007004, 10454500012010, 10472500007013, 10490500011016, 10516500013008, 10526550009006, 10445500006004, 10454500012022, 10472500007015, 10490500012022, 10516500018004, 10527500015012, 10445500006008, 10454500013012, 10472500007024, 10490550003008, 10517500014008, 10543500012008, 10445500007002, 10454500015016, 10472500008024, 10517500015000, 10543500012016, 10445500009008, 10454550003006, 10472500010012, 10517500024004, 10543500013004, 10445500016006, 10454550003020, 10472500013006, 10517550008008, 10543500015020, 10445550001001, 10454550005006, 10472500013012, 10518500013008, 10544500004005, 10445550002016, 10454550006008, 10472500014006, 10518500014006, 10544500004015, 10445550003010, 10455500003002, 10472550003002, 10518500017004, 10544500015000, 10446500002009, 10455500007012, 10472550003004, 10518500020004, 10544500017006, 10446500005002, 10455550001016, 10472550007014, 10518500021002, 10544500022010, 10446500005016, 10455550002010, 10473500003024, 10524500014012, 10545500016010, 10446500006006, 10458550000022, 10473500008016, 10525500016004, 10553500016000, 10446500009012, 10459500004002, 10473550000009, 10525500016008, 10553500019000, 10446550002006, 10461500003008, 10473550001012, 10525500017004, 10561500009008, 10447500004008, 10461550001016, 10474550000012, 10525500018016, 10561500010008, 10447550000002, 10462500009006, 10475500004016, 10525500020012, 10562500012000, 10447550000010, 10462550000010, 10480500002008, 10526500011024, 10562500012022, 10448500004018, 10463500008018, 10480500005000, 10526500013022, 10562500014000, 10451500004022, 10463550001006, 10481500006004, 10526500015000, 10562500015000, 10452500004002, 10463550004004, 10481500008006, 10526500016000, 10562500015004, 10453500005000, 10464500003004, 10481550002000, 10526500016004, 10562500016000, 10453500005006, 10464500005012, 10481550002012, 10526500017012, 10562500019008, 10453500007022, 10464550001008, 10481550003010, 10526500018004, 10562500021002, 10453500009004, 10470500005022, 10483500003020, 10526500019014, 10562500021012, 10453500009020, 10470500006007, 10485500004016, 10526500020004, 10562500022012, 10453550000017, 10470500010016, 10488500003008, 10526500020008, 10438550000004, 10453550002010, 10471500005008, 10489500004006, 10526500021002, 10439500004010, 10454500007004, 10471500006022, 10489500004014, 10526500021016, 10439550000004, 10454500008002, 10471500008016, 10489500005016, 10526500022006, 10439550000009, 10454500008014, 10471500008018, 10490500006000, 10443500007006, 10451550002006, 10453500011010, 10453500004022, 10463500005000, 10463500009010, 10463500008014, 10464500007006, 10469550000020, 10471500006006, 10471550001006, 10471500003008, 10471500004008, 10471500003014, 10472500007000, 10472500006004, 10472500007004, 10479500004008, 10490500007010, 10509550003010, 10524500010010, 10456500005004, 10535500013000, 10543500013006, 10543500014006, 10543500014014, and 10544500013000.

FDA is ‘aware’ of the situation (as I reported on September 22nd) but has not issued a recall notice or health alert. Neither has Health Canada.

As part of my September 22nd article, I posted a total of 14 reports of corneal abrasion, tears and eye pain caused by the recalled CooperVision lenses that I had received from readers. Later that day, I received the following:

From Court, on September 22:- Picked these up on a wednesday. Friday I tore off half my cornea in one eye and scratched the hell out of the other. I have been wearing contacts for over 10 years and i have never had this issue. Pasco, Washington is where I purchased them. Today I got a call from 1800contacts telling me about this recall. I looked up my lot # as advised and they are part of the recalled batch My new eye doctor is meeting with her associates to discuss how they plan on dealing with their patients’ needs. Has anyone heard or filed a class action law suit? I missed a day of work, ruined my labor day weekend and put me through hours/days of pain.

And this comment was just posted to eFoodAlert by Molly Martin, of CooperVision:

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).

To find out whether your contact lenses are affected by this recall, either refer to the list of recalled lot numbers (above), contact CooperVision directly using the information provided by Molly Martin, or use the “Search” feature on CooperVision’s recall web page.

FDA’s – and Health Canada’s – lack of public comment on this recall is nothing short of scandalous. How many more people must suffer eye injury before these agencies do their jobs?

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!