CooperVision Avaira Toric Contact Lens Recall Most Serious Type, FDA Says

CooperVision Inc.’s recent recall of Avaira Toric contact lenses has been deemed Class 1 by the U.S. Food & Drug Administration (FDA). Class 1 recalls are the FDA’s most serious type of recall, and means the agency has determined there is a reasonable probability the <"">CooperVision Avaira Toric contact lenses will cause serious eye injuries.

In a safety alert issued Friday, the FDA said the CooperVision Avaira Toric recall was issued because of a silicone oil residue that could cause users to suffer problems ranging from hazy, blurry vision and discomfort to eye injuries requiring medical treatment. According to the alert, the U.S. Avaira Toric recall includes some 778,301 lenses.

The FDA says it has received at least 15 reports of injuries related to the recalled lenses, including severe injuries such as corneal tears. The recalled lenses were manufactured between November 1, 2010 through August 3, 2011. The Avaira Toric contact lenses were sold through retailers, including Costco, Walmart and LensCrafters, and by eye care professionals.

The original CooperVision contact lens recall notice issued August 19 had indicated that only around 600,000 lenses were involved. The original notice also said the residue was unidentified, and only noted that some contact lens users had experienced hazy vision. The U.S. recall was actually part of a worldwide action that involved 8 million lenses.

CooperVision only issued the original notification letter to U.S. and Canadian distributors and health care practitioners who sold the lenses, and some users complained they never heard about the recall prior to experiencing a problem. Last week, MSNBC reported that more than a dozen Avaira Toric contact lens wearers had suffered painful eye injuries, including torn corneas and corneal abrasions, often resulting in the need for emergency treatment.

The FDA demanded the company broaden its notification, after determining the original warning did not adequately publicize the potential for problems caused by the recalled contact lenses. After the FDA threatened to publish its own warning, CooperVision issued a public notification last week.

The FDA is advising contact lens wearers to go to the CooperVision recall web page at, 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.

Consumers should return their lenses to their eye care practitioner or point of purchase if they have the affected contact lenses. In addition, if a consumer 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.

According to MSNBC, some consumers have reported eye problems with other brands of CooperVision contact lenses, but no others have been recalled.

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