The U.S. Food and Drug Administration (FDA) was forced to upgrade the recall status of CooperVision Avaira Toric contact lenses on October 14, 2011, after silicone oil residue was found on the lenses of specific lots. The presence of silicone oil residue may significantly increase the risk of blurred vision, discomfort, or eye injuries that require medical attention. Since the initiation of the original recall, the company has received additional complaints of severe eye pain as well.
CooperVision Avaira Toric Contact Lens Recall Update: November 16, 2011 – CooperVision announced that it is expanding its worldwide recall of the Avaira brand product line of contact lenses to include a limited number of lots of Avaira Sphere contact lenses because they did not meet the updated quality requirements due to the level of a silicone oil residue.
If you or a loved one has been injured by CooperVision Avaira Toric contact lenses, you should
CooperVision Avaira Toric Contact Lens Recall Overview
Avaira Toric contacts are considered the next generation in 2-week silicone hydrogel therapy. They provide contact wearers with the option to wear a lens that has the exceptional ability to stay moist and transmit high levels of oxygen through the lens. The revolutionary material is able to bind water in the lens without the need for any additional surface treatment. Therefore, those who wear them are supposedly provided with a product that offers consistent comfort and unparalleled visual performance.
Unfortunately, officials found the unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Subsequently, CooperVision, in association with the FDA, was forced to initiate a worldwide recall because of the contaminant. On August 19, 2011, the firm sent a recall notification letter to U.S. and Canadian distributors and health care practitioners. Foreign distributers of the contact lenses were sent a recall letter the following week.
However, October 14 witnessed the FDA upgrade their recall classification when it was discovered that silicone oil on the lenses may cause symptoms that range from hazy, blurry vision, discomfort in the eye and injuries requiring medical treatment. The FDA raised the recall to a Class 1 medical device recall, their most severe denomination, after acknowledging the dangers associated with the contaminated lenses. Class 1 recalls suggest that there is a reasonable probability that the use of these products will cause serious adverse health consequences.
Affected CooperVision Avaira Toric Contact Lenses
According to a Class 1 FDA Recall notification, the contaminated products included in the CooperVision Avaira Toric soft contact lens recall were manufactured from November 1, 2010 through August 3, 2011. The lenses come in packages of six and are used for the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had the natural lens of the eye removed. It is estimated that nearly 778,301 lenses were distributed within that period. However, authorities suggest that approximately 600,000 lenses in the U.S. are affected by the recall.
CooperVision Avaira Toric Contact Lens Injuries
According to reports, at least 12 individuals have acknowledged that they have suffered impaired vision, excruciating pain or been hospitalized after wearing the contaminated contacts. A 15-year-old woman, from Hampton, VA, was hospitalized on August 21 after using Avaira Toric contact lenses from a newly opened box. Doctors confirmed a severe tear and the girl was treated with pain medication and antibiotics. The following injuries have also been associated with the lenses in question:
- Torn corneas
- Corneal abrasions
- Blurred vision
- Impaired vision
- Significant eye pain
Do I Have a CooperVision Avaira Toric Soft Contact Lens Recall Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in CooperVision Avaira Toric soft contact lens lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by CooperVision Avaira Toric soft contact lenses, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.