6 Million Avaira Sphere Contact Lenses Added to CooperVision RecallNov 16, 2011 | Parker Waichman LLP
A month after it came under fire for its handling of the Avaira Toric contact lens recall, CooperVision Inc. is expanding the recall to include another Avaira brand. The expansion involves 6 million Avaira Sphere contact lens, 4.9 million of which were shipped to consumers.
According to a statement from the company, CooperVision is expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.
The presence of the silicone residue also prompted CooperVision's earlier recall of 778,000 Avaira Toric lenses. Those contact lenses were recalled after dozens of users reported eye injuries, including corneal tears and corneal abrasions that required emergency care. The U.S. Food & Drug Administration (FDA) deemed the Avaira Toric recall a Class I recall, meaning it had determined that there was a reasonable probability that using the recalled Avaira Toric lenses will cause serious injuries or death.
CooperVision was criticized in October when the first Avaira Toric contact lens recall came to light, for issuing in August what some referred to as a "stealth" recall. 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. The company didn't widen its notification of the recall until October, under pressure from the FDA.
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.