CooperVision Expands Contact Lens Recall

CooperVision’s contact lens recall has expanded to include a second Avaira® product. The expanded worldwide recall affects 4.9 million Avaira® Sphere contact lenses that may be contaminated with silicone oil residue. FDA is aware of the expanded recall.

The presence of silicone oil residue on the contact lenses “… may cause hazy vision or discomfort, severe eye pain or eye injuries requiring medical treatment,” according to the company’s news release.

In August 2011, CooperVision quietly recalled a limited number of production lots of Avaira® Toric contact lenses due to a “residue” problem. The recall, which was expanded in late September to include additional production lots, affected consumers in the USA, Canada, Hong Kong, Australia, Spain, Germany and Italy.

The Avaira® Toric recall was not widely publicized via a US Food and Drug Administration Class I recall notice until October 14th, after repeated reports were published by eFoodAlert and after MSNBC.com carried an October 11th article by JoNel Aleccia.

Today’s recall announcement affects consumers in several countries worldwide. CooperVision will launch a web site on November 16th where Avaira® users will be able to determine whether their lenses are affected by the recall.

Although consumers have complained to FDA and to eFoodAlert about problems with other CooperVision contact lens brands – most notably, ProClear and Frequency 55 contact lenses – only Avaira lenses are included in the expanded recall. Silicone oil is not used in the manufacturing process for these other brands.

As of late October, FDA received at least 40 Adverse Event Reports on various CooperVision contact lenses. Twenty-three of the reports complained about Avaira® lenses, including two that specifically mentioned Avaira Sphere. Ten consumers cited problems with ProClear lenses, and three mentioned Frequency 55 Toric contact lenses. As of today (November 15th) eFoodAlert has received 44 complaints from wearers of CooperVision contact lenses, including Avaira, ProClear and Frequency 55.

Notwithstanding this complaint pattern, I was informed last month by Morgan Liscinsky of FDA that the agency was satisfied with CooperVision’s performance. “The FDA,” Liscinsky told me on October 27th, “does not have any information at this time that would indicate that this voluntary recall would be expanded to include other CooperVision contact lens brands.”

For links to prior eFoodAlert articles relating to the CooperVision contact lens recalls, please click on the Toric Recalls tab at the top of the page. I’ll be updating this list to include more information on the latest recall as additional details become available.