FDA Threatens Public Warning over Recalled Contact Lenses

Frustrated by a brazen disregard of its request, the U.S. Food and Drug Administration (FDA) is threatening to widely publicize potential problems with recalled contact lenses made by a western New York firm and sold in stores such as Costco, Wal-Mart and Lenscrafters.

CooperVision Inc. of Fairport, N.Y., (located nine miles east of Rochester) reportedly has failed to heed a request by the FDA to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August due to unidentified “residue.” Company executives said the recall affected about 600,000 contact lenses in the United States, or 10 percent of those sold or issued domestically as samples.

“Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses,” FDA spokeswoman Morgan Liscinsky told msnbc.com in an email.

Such sharing, however, may be a little too late for consumers who allegedly suffered impaired vision, excruciating pain or landed in emergency rooms after wearing the contact lenses. The contacts were on the market for only four months, having been launched in April and recalled in August. “It is very frustrating that they’re not more vocal about it and that the FDA hasn’t warned more people,” Mellissa Cotton of Atlanta wrote in her email to msnbc. The 40-year-old said she suffered two corneal abrasions over the summer after wearing Avaira Toric lenses. “Next to labor, a corneal abrasion is one of the most painful things you can have.”

Dan O’Neil of Hampton, Va., claimed the recalled lenses tore his daughter’s cornea. “I noticed what looked like a torn piece of contact on her eye,” O’Neil said of the Aug. 21 mishap (which, incidentally, involved lenses from a newly-opened box from Wal-Mart). “Upon closer examination, I realized that what I was seeing was Erin’s cornea torn and rolled back.”

Doctors confirmed a severe corneal tear and treated the injury with both pain medication and antibiotics. O’Neil said neither he nor the ophthalmologist that treated his daughter were aware of the recall before the injury occurred.

CooperVision officials, however, have claimed they initiated a recall after investigating a “small number of unexpected wearer reports of hazy vision and discomfort,” according to msnbc.com. The voluntary recall began on Aug. 19 with a “limited number of lots” in the U.S. market; about a week later, the company told the FDA about the recall.

A notice posted on the company’s website includes a fill-in box where customers can check to determine whether their supply of contact lenses is affected. And while the notice provides details about the recall, possible injuries and symptoms, and steps to take to return tainted product, CooperVision does not provide customers with a list of retailers that sell the lenses, nor does it offer a complete list of affected lot numbers.

It does, however, offer an apology to consumers: “We at CooperVision take great pride in the quality of our products,” the website notice reads. “We initiated a voluntary recall after investigating a small number of unexpected wearer reports of hazy vision and discomfort. The wearer symptoms were temporary in many cases. This recall involves only a slight percentage of Avaira Toric lenses…We apologize for any inconvenience this recall may have caused and are working hard to make this process as smooth as possible.”

Retailers were quick to notify customers about the Avaira Toric recall—Costco notified about 2,600 customers of potential problems with the lenses either the same day that CooperVision issued the recall or soon thereafter, according to a company spokesman. Wal-Mart notified its optical departments on Aug. 24, while LensCrafters reportedly notified customers immediately through its retail stores.

Those moves, though, followed wider international notification of the defective lenses, including recalls issued in Hong Kong, China; Australia and Spain, where the public notice included a list of more than 200 affected lots. The Hong Kong notice indicates that Avaira Toric lenses also were recalled in Canada, Germany and Italy.

But CooperVision has not yet issued a wider recall notification in the United States that FDA officials are seeking. “We are requesting the firm issue a broader statement to ensure that users are aware of the recall,” Liscinsky wrote in an email to msnbc.

CooperVision executives claim the firm is fully cooperating with the FDA. In a statement to msnbc.com, a spokeswoman said the company “continues to closely monitor the situation and seek advice from the FDA during this process.”