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U.S. Department of Health and Human Services

Medical Devices

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CooperVision AVAIRA Toric and Sphere Soft Contact Lenses

Recall Class: Class I

Date Recall Initiated: August 19, 2011; expanded on November 15, 2011

Product(s): AVAIRA (enfilcon A) TORIC and SPHERE soft (Hydrophilic) Contact Lenses

The Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses.

Go to the CooperVision recall web page at www.coopervision.com/international-recall,disclaimer icon 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.

The recalled Avaira Toric Soft Contact Lenses were manufactured from November 1, 2010 through August 3, 2011. Approximately 778,301 lenses were distributed.

The recalled Avaira Sphere Soft Contact Lenses were manufactured from February 1, 2011 through August 24, 2011 and distributed from March 2, 2011 through November 15, 2011.

Use: For the correction of nearsightedness or farsightedness, with or without 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 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:

Based on a conversation with the firm, the FDA has agreed that the Avaira Sphere Contact Lenses recall is an expansion of the Class I recall of CooperVision’s Avaira Toric Contact Lenses.

On August 19, 2011, the firm sent a recall notification letter to the Avaira Toric Contact Lens worldwide distributors and health care practitioners. On November 19, 2011, the firm sent a recall notification letter to the Avaira Sphere Contact Lens worldwide distributors and health care practitioners.

Affected contact lens wearers should stop wearing their lenses immediately and contact their eye care practitioner for advice. Avaira contact lens wearers should check CooperVision’s recall web site www.coopervision.com/international-recalldisclaimer icon to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Alternatively, consumers can contact CooperVision’s toll-free consumer hotline at 1-855-526-6737 (M-F, 9:00 am – 5:00 pm EST). If you discover your lenses are among the recalled lots, return them to the point of purchase or to your eye care practitioner.

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.

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