CooperVision, the manufacturer of the popular Avaira Sphere and Avaira Toric contact lenses, has issued the recall after users complained of eye injury after using the products. They found that the lenses were contaminated with a dangerous silicon oil residue.
CooperVision Contact Lens Recall
CooperVision, the company that manufactures and distributes the best-selling Avaira Toric and Avaira Sphere contact lenses, has been forced to recall more than five million products after consumers complained that they suffered serious eye injuries after they used the products. The lenses are approved by the FDA to treat the symptoms of nearsightedness (myopia), farsightedness (hyperopia), and astigmatism, which cause blurry vision.
Since August, the recall has expanded immensely, as the company discovered more and more products contaminated with dangerous silicon oil residue. The company has since notified the FDA, warned the public, and dramatically expanded its recall.
Some people have experienced: temporary eye pain, hazy vision, and blurred vision. A small number of people have experienced far more severe symptoms — including vision loss, requiring medical treatment. If you experience any vision problems after using a contact lens, contact an emergency physician immediately.
Class 1 FDA Recall
CooperVision products are under a Class 1 FDA recall — the highest level, reserved for extremely dangerous products that have a high, immediate risk of causing harm. Other examples of Class 1 recalls are: labeling mistakes on prescription pills, food contaminated with bacterial pathogens, and defective artificial heart valves.
What contact lenses are affected?
The recall affects Avaira Sphere and Avaira Toric lenses manufactured between February 1, 2011 and August 24, 2011. You may have purchased them between March 2, 2011 and November 15, 2011.
History of the Recall
- 1) Consumers were first notified of contamination in August 2011 — CooperVision initiated a small recall of Avaira Toric contact lenses
- 2) On November 16, 2011, the recall expanded to include Avaira Sphere, in addition the Avaira Toric products. The recall affected more than 600,000 products.
- 3) On December 7, 2011, the recall expanded dramatically — now, it includes at least five million products, all due to the unfortunate contamination with silicon oil residue.
What should I do?
- Immediately, stop wearing the contact lenses.
- Store your contact lenses and the box somewhere safe — The lot number is on the box, and you will need the lot number to find out if your contacts are part of the enormous recall.
- On the CooperVision website, there is a box to search for your lot number. Or, you can call the Customer Care hotline at 1-855-526-6737. Even if your contact lenses are not part of the recall yet, it may expand to include your number.
- Contact your optometrist. Tell them that you have been injured, and ask him/her to report your case to the FDA. The FDA needs to collect information on dangerous medical device injuries so it can better protect the public. Or, call the FDA yourself: 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.