CooperVision Expands its Contact Lens Recall

The contact lens crisis continues at CooperVision Inc. Executives with the Fairport, N.Y.-based firm are recalling a second brand of Avaira contact lenses that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.

The addition of Avaira Sphere lenses to an August recall of Avaira Toric contact lenses occurs just weeks after U.S. Food and Drug Administration (FDA) officials threatened to issue a widespread public notice about potential hazards associated with the Toric brand. The FDA accused CooperVision of issuing a “stealth recall” over the summer that left many consumers unaware of the problem.

The FDA has issued a Class 1 recall warning about the products and pressured the firm in October to inform more people about the 780,000 potentially dangerous Avaira Toric lenses in circulation on the market. Class 1 recalls are the most serious kind of notice issued by the FDA; they usually involve problems in which there is a reasonable chance of serious adverse health consequences or death.

The problems associated with the Avaira brand are not deadly, but they nonetheless are serious: hazy vision, pain and torn corneas. CooperVision spokeswoman Denise Powell said a total of 6.6 million Avaira Sphere contact lenses are affected by the recall, though only 4.9 million were shipped to stores such as Costco, Lenscrafters and Wal-Mart.

The Avaira Toric recall affected about 10 percent of the total number of lenses sold or issued domestically as samples. The contacts were on the market for only four months, having been launched in April and then recalled in August. The voluntary recall began on Aug. 19 with a “limited number of lots” in the U.S. market; about a week later, the company informed the FDA about the recall.

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.

CooperVision officials claim the recall is limited only to the Avaira Toric and Avaira Sphere brand (both products use silicone oil in their manufacture). The company expects to set aside about $9 million for the expanded recall and $23.2 million on both recalls, according to a news release.

The firm has devoted a section of its website to the recall that explains the cause and provides instructions to consumers who may have purchased the contaminated lenses. “If you experience hazy vision or unusual discomfort with your Avaira lenses, please remove [the lenses] immediately and contact your eye care practitioner. You can check to see if your lenses are part of the limited recall by checking the lot number as indicated…” the website notice read. “If your lenses are affected even if you’re not experiencing symptoms please contact your eye care professional.”

The company also offered an apology to consumers: “We sincerely apologize to those customers who have experienced problems with the affected lenses or have the affected lenses in their possession. CooperVision has more than 30 years of experience manufacturing high quality contact lenses, and we take our consumers’ eye health and safety very seriously. We strive to ensure all wearers have a positive experience with our products.”

Consumers with problems or questions related to the recalls should contact CooperVision at (855) 526-6737.