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!

Recalls and Alerts: September 21, 2011

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

  • Allergy Alert: M & P Food production Ltd. (Brooklyn, NY) recalls Bapehuku, Babushka, Russian, and Siberian brands of chicken, beef, veal and pork dumpling products, because they may contain undeclared milk. The recalled products were manufactured between March 18th and Sept. 19th, 2011 and distributed to retailers in Connecticut, Florida, Massachusetts, North Carolina, New Jersey, New York, Ohio, Pennsylvania, and South Carolina.
  • Food Safety Recall: Roundy’s Supermarkets Inc. (Milwaukee, WI) recalls Chef’s Collection Chicken Milanese Breast (Item code 037496; Lot code 171589-2561), because the products may have been undercooked. The recalled chicken breast products were sold in Copps, Mariano’s, Metro Market, Pick ‘n Save and Rainbow Foods stores in Illinois, Minnesota and Wisconsin.

Canada

  • Allergy Alert: Asti Holdings Ltd. (New Westminister, BC) recalls Nougat d’Or brand Honey Almond Nougat, Honey Almond Nougat with Cranberries, and Honey Almond Nougat with Orange (130g packages; Lot #111591111, 113541011, and 110241111), because the products may contain undeclared milk. The recalled products were sold in Alberta and British Columbia.

Europe

  • Allergy Alert (UK): Tesco recalls Tesco Free From Pure Oat Fruit Muesli (450g; Best before 20 May 2012, 22 May 2012, 18 June 2012, 19 June 2012) and Tesco Free From Pure Porridge Oats (450g; Best before 22 July 2012, 25 July 2012, 17 August 2012, 18 August 2012, 8 September 2012), because the products may contain low levels of gluten.
  • Allergy Alert (UK): Asda recalls Asda Chosen by You Oat Muesli (Free From), 450g (Best before 03/08/12) and Asda Chosen by You Porridge Oats (Free From), 450g (Best before 02/08/12 and 07/09/12), because the products may contain undeclared wheat gluten.

Asia, Africa and the Pacific Islands

  • Outbreak Alert (Lebanon): The Ministry of Health is investigating a number of reports of food poisoning among people in Kesrouan who ate Arabic sweets from a shop in the area, according to a story on Now Lebanon.

Australia and New Zealand

  • Food Safety Recall (New Zealand): Fonterra Brands (New Zealand) Ltd recalls Mainland Tasty Cheese cracked pepper processed slices (500g, 700g, & 1kg blocks; various Best before dates), after a metal fragment was found in a single pack of cheese. Please refer to the recall notice for a list of affected lots.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Listeria Outbreak: Another Day, Another Death

Colorado has registered a second death in the lethal outbreak of Listeria monocytogenes that was traced to contaminated cantaloupes from Jensen Farms in Holly, CO. The state now confirms 14 outbreak cases of the bacterial illness, up from 12 cases just two days ago.

In all, sixteen states report confirmed or suspect outbreak cases. In additional to the basic information available in the CDC Investigation Update, several of these states have released more details about the victims in their states, either on their websites, in news media articles, or in response to my email enquiries.

Here is what we know, as of today:

  • California:- 1 confirmed outbreak case; none of the recalled cantaloupes were shipped to California.
  • Colorado:- 14 confirmed outbreak cases, including 2 deaths.
  • Illinois:- 1 confirmed outbreak case; no additional cases under investigation at this time. The infected individual is an 82-year-old woman from suburban Cook County. She became ill on September 7th, and was subsequently hospitalized.
  • Indiana:- 1 confirmed outbreak case. None of the recalled cantaloupes were shipped directly to Indiana.
  • Kansas:- 8 cases under investigation, including 2 deaths. Additional lab testing is pending.
  • Maryland:- 1 fatal confirmed outbreak case. None if the recalled cantaloupes were shipped directly to Maryland.
  • Missouri:- 2 cases under investigation. One death.
  • Montana:- 1 confirmed outbreak case in Yellowstone County; 1 suspect case from Gallatin County. Recalled cantaloupes were not shipped directly to Montana.
  • Nebraska:- 4 confirmed outbreak cases, all 70+ years old; two victims are 90+ years old. All four victims were hospitalized. There were no deaths.
  • New Mexico:- 10 confirmed outbreak cases, including 4 deaths. All 10 individuals were hospitalized. Victims’ ages range from 43 to 96 years, and include 6 women and 4 men. Patients are from seven different New Mexico counties.
  • Oklahoma:-  8 confirmed outbreak cases, including one death. Two additional cases are under investigation. Outbreak-related illnesses have been reported from Oklahoma, Canadian, Cleveland, Love and McCurtain counties. Victims range from 61 to 96 years old; two-thirds are male.
  • Texas:- 9 confirmed outbreak cases.
  • Virginia:- 1 confirmed outbreak case. Recalled cantaloupes were not shipped directly to Virginia.
  • West Virginia:- 1 confirmed outbreak case. Recalled cantaloupes were not shipped directly to West Virginia.
  • Wisconsin:- 2 confirmed outbreak cases. Recalled cantaloupes were not shipped directly to Wisconsin.
  • Wyoming:- 1 confirmed outbreak case.

In total, 16 states have reported at least one confirmed or suspect Listeria monocytogenes illness. Fifty-five cases of Listeria monocytogenes are confirmed to be part of this outbreak; 8 out of 55 (14.5%) confirmed outbreak victims have died. Of the 13 illnesses under investigation, 3 were fatal.

The totals are tragic.

  • Eleven people dead.
  • 68 infected in 16 states.
  • Overall death rate of 16.2%.

One of the frightening – and frustrating – aspects of this outbreak for US consumers is that no one in authority is releasing information on where the contaminated cantaloupes were sold. FDA has said nothing. Jensen has said nothing. Colorado has said nothing. Only a few supermarket chains have posted recall information.

In my email request for information, which I sent to all 50 states, I specifically asked the question, “Can you provide any information on which retailers in your state sold the implicated melons?” Not a single state responded to that question substantively.

Food recalls rarely are 100% effective. Some supermarket chains are better than others at passing the word to individual store managers. Some stores never act on the recall notice, whether through overwork, ignorance or inertia.

Consumers have the right to know where a recalled food was sold, so that they can act to protect themselves. The  refusal of FDA and most state agencies to provide this information is unconscionable. And it puts the health of the general public at risk unnecessarily.

In the absence of an official retail distribution list, a consolidated list of the limited recall information that is available can be found at “Did Your Supermarket Sell Colorado Cantaloupes?”

Finally, the Oklahoma State Department of Health (OSDH) has the following recommendation for consumers:

“The OSDH recommends individuals to be aware that recalled cantaloupes may still be in consumers’ homes. The OSDH recommends that persons at high risk for listeriosis, including older adults, persons with weakened immune systems, and pregnant women, not eat cantaloupes shipped by Jensen Farms. A label on the cantaloupe will have the Jensen Farm brand. Consumers who have cantaloupes in their homes can check the label or inquire at the store where they purchased it to determine if the fruit was marketed as coming from Jensen Farms. Cantaloupes marketed as coming from Jensen Farms should be not be consumed and should be discarded.”