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.

CooperVision Revisited

Since January 28, 2011, FDA has received a total of 42 Adverse Event Reports relating to contact lenses.

Twenty-three of these reports specifically complained about Avaira lenses (15 Avaira Toric, 6 Avaire and 2 Avaira sphere). An additional 10 reports cited problems with Proclear lenses; three consumers reported difficulties with Frequency 55 Toric lenses, 2 with Sofmed Breathable Toric Enfilcon A, and one each cited Biofinity CL, Coopervion (sic), and One-day Trueye CL Narafilcon A. One Adverse Report did not provide a brand identification.

Except for the One-day Trueye lenses (a Johnson & Johnson product) and the “unknown” brand, all of the lenses cited by consumers as producing adverse reactions were manufactured by CooperVision.

CooperVision went public with its recall of Avaira® Toric contact lenses on October 13, 2011 – nearly two months after quietly posting a recall notice on its website and alerting its distribution network to the recall.

The company has given no indication of expanding its recall beyond the Avaira® Toric lenses. Yet FDA acknowledges receiving 17 Adverse Event Reports on other CooperVision brands, most notably Proclear and Frequency 55. And several eFoodAlert readers also have reported problems with both Proclear and Frequency 55 contact lenses.

Adverse Event Reports have their limitations. According to FDA’s Morgan Liscinsky, there is no certainty that a reported adverse reaction actually was due to the product cited in a report, and sometimes there are not enough details provided to allow FDA to evaluate an “event” properly.

While these limitations exist, the great preponderance of Adverse Event Reports associated with CooperVision lenses (40 out of 42) seems to defy the laws of random chance.

Nevertheless, FDA has put its stamp of approval on CooperVision’s performance. “CooperVision’s handling of their voluntary recall of Avaira Toric contact lenses,” says Liscinsky, “is consistent with the Agency’s expectations for a Class I recall.”

FDA will continue to monitor the effectiveness of the recall, but gives no indication of pursuing the questions raised about other CooperVision brands. “The FDA,” Liscinsky explains, “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.”

CooperVision Avaira® Toric Recall Goes Public

October 14, 2011.- Today – almost two months after issuing a “recall notification letter” to its US and Canadian distributors and health care practitioners, CooperVision’s recall notice finally appeared on FDA’s website.

The essential details of the formal recall notice are as follows:

Recall Class: Class I (Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.)
Date Recall Initiated: August 19, 2011
Product(s): AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. The lenses were manufactured from November 1, 2010 through August 3, 2011. Consumers wanting to determine whether their lot code was recalled can use the search box on the CooperVision recall web page at http://www.coopervision.com/recall or call the toll-free consumer hotline at 1-855-526-6737.
Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Please refer to the Recall Notice for additional information and instructions.

As I reported yesterday, FDA has received a total of 42 “adverse reaction” reports from contact lens wearers. Only 15 of those 42 reports were associated with Avaira® Toric contact lenses. According to FDA spokeswoman Morgan Liscinsky, several other brands manufactured by CooperVision have been the subject of consumer complaints, including Frequency 55 Toric, Proclear, Sofmed, and Enfilcon A contact lenses.

Several eFoodAlert readers also have reported eye discomfort and injuries associated with wearing Frequency 55 and Proclear contact lenses, in addition to many others who experienced corneal abrasions after wearing Avaira Toric lenses.

While I am pleased and relieved to see that CooperVision finally has consented to issue a Class I Recall Notice, I can’t help wondering whether this would have happened without the story published by JoNel Aleccia of msnbc.com on October 11th.

I also wonder how much more time must pass before CooperVision acknowledges that their problem extends beyond the Avaira Toric brand.