CooperVision Contact Lens Recall Given Class 1 StatusOct 17, 2011 | Parker Waichman LLP
The Food & Drug Administration (FDA) has assigned its most serious recall classification - Class 1 - the recent CooperVision Avaira Toric contact lens recall. It also seems that the U.S. CooperVision contact lens recall involves more lenses than first thought, 778,301 to exact.
In a notification sent to distributors and eye care professionals on August 19, CooperVision stated only around 600,000 lenses were involved in the Avaira Toric contact lens recall. Of course, the company also indicated that the problems reported by users of the defective contact lenses were limited to hazy vision.
But we now know, thanks to a report from MSNBC, that problems reported by users of the contacts included corneal tears and corneal abrasions, sometimes forcing victims to rush to the emergency. According to the FDA, it's received 15 reports of serious eye injuries linked to the Avaira Toric lenses. The Class I status means the FDA has determined that there is a reasonable probability that using the recalled Avaira Toric lenses will cause serious injuries or death.
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.
The FDA is advising contact lens wearers to go to 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.
The U.S. Avaira Toric recall was part of a worldwide action that involved 8 million lenses. According to MSNBC, some consumers have reported eye problems with other brands of CooperVision contact lenses, but no others have been recalled.