Class I Status Given to CooperVision Avaira Sphere Contact Lens RecallDec 7, 2011 | Parker Waichman LLP
Like the previous Avaira Toric contact lens recall announced in August, the U.S. Food & Drug Administration (FDA) has decided to classify CooperVision's Avaira Sphere contact lens recall Class I, its most serious type of recall action. Class I recalls involve situations in which the FDA has determined there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The CooperVision Avaira Sphere contact lens recall was announced on November 15. It involved over 6 million Avaira Sphere contact lenses, 4.9 million of which were shipped to consumers. The recall was an expansion of an August action that involved roughly 800,000 Avaira Toric contact lenses, including 600,000 in the U.S. That recall was announced in August, and deemed Class I by the FDA in October.
Both recalls were issued because of the possible presence of a silicone residue on the lenses. CooperVision was heavily criticized for its handling of the original Avaira Toric contact lens recall, after only notifying U.S. and Canadian distributors and health care practitioners who sold the lenses. However, after coming under pressure from the FDA, CooperVision issued a wider notification to consumers in October.
CooperVision has also been accused of at first downplaying eye problems caused by the lenses, after characterizing them as mostly reports of "hazy vision." But according to media reports, users of the recalled contact lenses suffered eye problems that required emergency medical attention, including eye pain, corneal abrasions and torn corneas. As of November 15, the FDA had received 40 reports of problems associated with various CooperVision contact lenses. Of those, at least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere.
Contact lens wearers should visit 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.
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 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.