CooperVision, the manufacturer of Avaira Sphere and Avaira Toric lenses, is issuing a recall of more than 5,000,000 products after discovering that they were contaminated with a dangerous silicon oil residue.
CooperVision Avaira Sphere Contact Lens Recall Lawsuit
CooperVision manufactures and distributes some of the world’s most popular contact lenses, approved to correct vision problems associated with myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. Recently, however, the company has been forced to issue a recall of more than 5 million Avaira Toric and Avaira Sphere contact lenses after consumers complained of eye injury after using the lenses — including vision loss. A subsequent company investigation found that the products were unintentionally contaminated with a silicon oil residue.
What is the problem? CooperVision is warning its customers that their contact lenses may cause temporary eye pain, hazy vision, and blurred vision. Every person will experience symptoms differently, however, and some people have experienced severe symptoms that required medical treatment. Contact an emergency physician immediately if you are using one of the recalled products and experience a severe side-effect.
Class 1 FDA Recall
This is a Class 1 FDA recall, which means that is belongs to the highest level of product recalls. This serious category is reserved for harmful products that carry a high risk of causing serious injury or death. Other examples of products that warrant a Class 1 recall are: label mix-ups on prescription drugs, food contaminated with harmful pathogens, and defective artificial heart valves.
What lenses are affected?
The recall affects Avaira Sphere and Avaira Toric lenses manufactured between February 1, 2011 and August 24, 2011. The products were distributed and sold from March 2, 2011 through November 15, 2011.
History of the Recall
- The first recall was in August 2011, when a small number of Avaira Toric contact lenses were found to be contaminated with silicon oil residue.
- The recall was expanded a few weeks later, on November 16, 2011, to more than 600,00 products — including Avaira Sphere contact lenses, in addition the Avaira Toric products.
- The recall has continued to expand. Most recently, on December 7, 2011, the recall includes at least five million contact lenses, all contaminated with the silicon oil residue that has caused serious vision injuries in some users.
What should I do?
- Do not wear the contact lenses.
- Put the contact lenses and the packaging in a safe place — you will need the box to find the lot number, which you can use to find out if your products are part of the massive recall.
- Go to the CooperVision website to check your lot number. You can also call the Customer Care hotline at 1-855-526-6737. If your lot number is not part of the recall, you may still be affected if the recall continues to expand.
- Call your optometrist or eye-care doctor, and ask them to contact the FDA and report your case. The FDA collects information on medical device injuries, and they should be notified. You can also call the FDA yourself at: 1-800-332-1088.
What is Astigmatism?
CooperVision contacts are used by millions of people to treat astigmatism, a vision problem people experience when the cornea (the clear tissue covering the front of the eye) is curved in a way that makes it difficult to focus light. A person with astigmatism will have blurry vision, both near and far. Eye discomfort, headaches, and other symptoms may also be associated with severe cases.
What is myopia (nearsightedness) and hyperopia (farsightedness)?
Millions of people also use CooperVision Avaira Sphere contact lenses to treat nearsightedness and farsightedness.
Myopia, or “nearsightedness,” is when a person’s vision is clear up close, but blurry at a distance. This vision problem happens when light coming in the eye is focused incorrectly. Myopia often worsens as a person ages, but it can be treated with corrective contact lenses (such as CooperVision’s Avaira Sphere or Avaira Toric), glasses, or corrective LASIK surgery.
Hyperopia, or “farsightedness,” is when a person can see things clearly at a distance, but not up close. Like myopia, it occurs when the person’s eye does not focus light properly. Farsightedness is treatable by using contact lenses or glasses.
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