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CooperVision Expands Contact Lens Recall

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Following designation of its recall as a Class I by the U.S. Food and Drug Administration (FDA), CooperVision just expanded its contact lens recall. Class 1 recalls are the FDA’s most serious type and indicate that the agency has determined there is a reasonable probability the recalled product will cause serious injuries.

Now, some 5 million contact lenses, which were shipped to consumers, are being recalled by CooperVision Inc. and include a second Avaira brand, said MSNBC. The lenses may be contaminated with silicone oil residue that has been associated with blurred vision as well as serious as eye injuries and pain, MSNBC said.

CooperVision Inc. officials said the firm added Avaira Sphere contact lenses to its August recall of Avaira Toric lenses, when specific lots did not meet quality standards due to oil residue, reported MSNBC, citing CooperVision’s press release. Company spokeswoman, Denise Powell, said that 6.6 million Avaira Sphere lenses were produced and affected by the recall, 4.9 million were shipped.

Since late last month, the FDA received at least 40 reports of problems linked to a number of CooperVision contact lenses, said MSNBC, citing FDA records. Of the complaints, at least 15 discussed Avaira Toric and two discussed Avaira Sphere, according to data provided by Phyllis Entis. Entis maintains the eFoodAlert blog.

MSNBC wrote that dozens of Avaira Toric users said they suffered from hazy vision, pain, and severe injuries, including corneal tears requiring emergency medical treatment. CooperVision was accused of using a “stealth recall” this August in which many consumers were not aware of the issues—some serious—linked to CooperVision contact lenses.

The prior FDA safety alert 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 significant eye injuries requiring medical treatment. According to the alert, the U.S. Avaira Toric recall included some 778,301 lenses manufactured from November 1, 2010 through August 3, 2011 and sold through retailers, including Costco, Walmart, and LensCrafters, and by eye care professionals.

The original CooperVision contact lens recall notice issued August 19 indicated that only around 600,000 lenses were involved. That 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. Following a number of injury and adverse reaction reports, the FDA demanded CooperVision 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.

Officials at CooperVision said no other product lines—other than the Avaira Toric and Avaira Sphere—utilize silicone oil in product manufacture, explained MSNBC. CooperVision can be reached at its toll-free consumer hotline at 1-855-526-6737.

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