Tags

,

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.”

Advertisements