CooperVision, the manufacturer of Avaira Toric Contact Lenses, is expanding its recall to include more than 5,000,000 lenses because they may cause serious eye problems, including loss of vision. The products were accidentally manufactured with a silicon oil residue.
CooperVision Avaira Toric Contact Lens Recall
CooperVision is a leading manufacturer of soft contact lenses, used for the correction of myopia (nearsightedness), hyperopia (farsightedness), and astigmatism. Unfortunately, the unintended presence of silicon oil residue on the contact lenses has prompted the manufacturer to recall over 5 million Avaira Toric and Avaira Sphere contact lenses because they may cause serious eye injury.
CooperVision is warning consumers that its contact lenses may cause temporary eye pain, hazy vision, and blurred vision. Some people have experienced severe symptoms that required medical treatment, including vision loss. If you are experiencing symptoms, contact an emergency physician immediately.
Class 1 FDA Recall History
The recall is a Class 1 FDA recall — the highest level, reserved for dangerous or defective products that could potentially cause serious harm or death. Examples of other products in this category are prescription medication label mix-ups, contaminated food, and defective artificial heart valves.
The recall affects lenses manufactured between February 1, 2011 through August 24, 2011. They were distributed and sold from March 2, 2011 through November 15, 2011.
History of the Recall
- August 2011 — A recall is announced on a small number of Avaira Toric contact lenses.
- November 16, 2011 — The recall is expanded to include Avaira Sphere contact lenses, in addition to the previously recalled Toric lenses. The recall includes approximately 600,000 products.
- December 7, 2011 — The recall is expanded yet again to include more than five million contact lenses, all contaminated with the silicon oil residue that has caused serious vision injuries in some users.
What should I do?
- Stop wearing the contact lenses immediately
- Save the contact lens packaging and the contact lenses. Keep them in a safe place. You will need the lot number to determine if your lenses are part of the recall.
- Check your lot number on the CooperVision website or call the Customer Care hotline at 1-855-526-6737 to see if your lenses are part of the recall. Even if your lot number is not among the current recall, it is possible that the recall will be expanded — it has already expanded from a few hundred thousand to millions of lenses.
- Contact your eye-care doctor to report you case to the FDA. The FDA should be notified of all serious contact lens side effects. You can contact the FDA directly at: 1-800-332-1088.
What is Astigmatism?
CooperVision’s Avaira Sphere and Avaira Toric are used by many people to treat symptoms associated with astigmatism, which is an eye problem that occurs when the cornea (the clear tissue covering the front of the eye) is abnormally curved. An eye with astigmatism is not able to focus light effectively, and a person will experience blurred vision at all distances. Severe astigmatism can cause eye discomfort and headaches.
What is myopia (nearsightedness) and hyperopia (farsightedness)?
CooperVision Avaira Toric contact lenses are also used by many people to treat nearsightedness and farsightedness.
Myopia, also known as “nearsightedness,” occurs when light entering the eye is focused incorrectly, making distant objects appear blurred. It usually grows worse as the person ages, and will usually require corrective contact lenses (such as CooperVision’s Avaira Sphere or Avaira Toric), glasses, or corrective LASIK surgery.
Hyperopia, also known as “farsightedness,” occurs when the eye does not focus light correctly, making it difficult to see near objects. Far objects still appear clearly. Farsightedness can be corrected using glasses, contact lenses, or surgery.