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Class I Medical Device Recall: CooperVision AVAIRA Toric Soft Contact Lenses

Fri, 10/14/2011 - 12:30pm
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: August 19, 2011

Product(s): AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism

Go to the CooperVision recall web page at www.coopervision.com/recall, and enter the package lot number to determine whether the lenses have been recalled or contact the toll-free consumer hotline at 1-855-526-6737.

These lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.

Use: For the correction of nearsightedness or farsightedness with astigmatism in persons who may or may not have had their natural lens of their eye removed and who has not had previous eye diseases with a lens powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The AVAIRA Soft Contact Lens is indicated for single-use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

Recalling Firm:

CooperVision Inc.

180 Thruway Park Dr.

W. Henrietta, New York 14586-9798

Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Public Contact:

Consumers may contact CooperVision on their toll-free hotline at 1-855-526-6737.

FDA District: New York

FDA Comments:

On August 19, 2011, the firm sent a recall notification letter to the US and Canadian distributors and health care practitioners. Other foreign distributors were sent the recall letter a week later.

Consumers should return their lenses to their eye care practitioner if they have the affected contact lenses. In addition, if a consumer who is wearing Avaira Toric contact lenses and experiences any symptoms, it is recommended that they stop wearing the lenses immediately and contact their eye care practitioner for advice.

If a consumer is wearing Avaira Toric contact lenses and is NOT experiencing symptoms, CooperVision recommends going to their recall web page at www.coopervision.com/recall and enter the lot number of their package to determine whether their lenses have been recalled. If the lenses are on the recall list, they should immediately remove their existing lenses, discontinue all lens wear, and return them to their eye care practitioner or point of purchase.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

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