The U.S. Food & Drug Administration (FDA) raised the nationwide recall of CooperVision's AVAIRA Toric Soft Contact Lenses for Astigmatism because they may cause hazy vision, discomfort, and severe eye injuries. The FDA has placed the recall into Class I, which is reserved for the administration’s strictest and most urgent recalls. If you have purchased CooperVision AVAIRA Contact Lenses included in this recall, you should immediately remove the lenses and return them to the place of purchase for a full refund.
What’s the problem?
October 17, 2011 - The source of the problem seems to be silicone residue on the lenses, which has caused a number of reports of severe eye pain from users since the original recall was issued on Aug. 13. The approximately 600,000 lenses being recalled were manufactured between Nov. 1 and August 3, 2011.
CooperVision's AVAIRA Toric Soft Contact Lenses come in a package of six, and are used for the treatment of nearsightedness and farsightedness with astigmatism. The lenses are powered from -20.00 to +20.00 diopters, and have astigmatic corrections ranging from -0.25 to -10.00 diopters. They are designed for single-use as well as daily wear.
Class I FDA recalls are reserved for dangerous or defective products that could potentially cause serious health problems or even death. Examples of products classified in this category include label mix-ups on prescription medications, food found to contain bacterial pathogens, and defective artificial heart valves.
What is Astigmatism?
Astigmatism is a common vision condition characterized by blurred vision either due to the irregular shape of the cornea (the clear front cover of the eye) or the curvature of the lens inside the eye. This prevents light from focusing properly on the retina, the light sensitive surface at the back of the eye. As a result, vision becomes blurred at any distance. Signs and symptoms of astigmatism typically include:
- Blurred or distorted vision
- Eye strain
- Headaches (especially after reading or other prolonged visual tasks)
In a recent study of more than 2,500 American children between the ages of five and 17, nearly 30% had astigmatism of 1.0 diopter (D) or greater. Additionally, the study noted some interesting differences in astigmatism based on cultural ethnicity. Asian and Hispanic children had the highest prevalences (33.6 and 36.9 percent, respectively), followed by whites (26.4 percent) and African-Americans (20.0 percent).
Myopia (Nearsightedness) & Hyperopia (Farsightedness)
Nearsightedness or myopia means an individual can see better up close than they can at a distance. The condition occurs because the eye is longer than normal, which tends to focus light in front of the retina rather than on the retina itself. CooperVision's AVAIRA Toric Soft Contact Lenses are designed to move the image from in front of the retina to on the retina itself.
Hyperopia or farsightedness means that you can see better far away than you can close up. In this case, the condition occurs because an individual’s eye is smaller than average. Since hyperopia is caused by the eye being smaller than average, the light that is focused in the eye lands behind the retina rather than on it. AVAIRA Contact Lenses are used to move the image from behind the retina on to the retina itself where it should be.