Nearly 5 million Contact Lenses In Expanded Avaira Recall.

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5 million contact lenses recalled for cornea risk.

Nearly 5 million contact lenses in expanded Avaira recall.
Nov:15-2011
Health News.

Nearly 5 million contact lenses shipped to consumers are being recalled by CooperVision Inc. in an expanded action that includes a second Avaira brand that may be contaminated with silicone oil residue and linked to blurred vision, eye injuries and severe pain.

CooperVision Inc. officials on Tuesday added Avaira Sphere contact lenses to an August recall of Avaira Toric lenses because certain lots failed to meet quality standards because of the oil residue, according to a press release from the company's Pleasanton, Calif., office. Denise Powell, a company spokeswoman, said the line produced 6.6 million Avaira Sphere lenses affected by the recall, but 4.9 million were actually shipped.

The move comes after the federal Food and Drug Administration issued a Class I warning about the products and pressured the company last month to increase public notice about the recall of nearly 780,000 Avaira Toric lenses. Class I recalls are the most serious kind and involve problems in which there is a reasonable chance of serious adverse health consequences or death.

As of late October, the FDA had received at least 40 reports of problems associated with various CooperVision contact lenses, agency records show. At least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere, according to data shared by Phyllis Entis, who maintains the eFoodAlert blog. An FDA official was not available to discuss the new recall Tuesday.

Dozens of Avaira Toric users reported problems ranging from hazy vision and pain to severe injuries, including torn corneas, which required emergency medical treatment. Company officials were accused of issuing a "stealth recall" in August that left many consumers unaware of the problem.

Company officials noted that no product lines other than Avaira Toric and Avaira Sphere use silicone oil to manufacture the products. The firm expects to set aside a reserve of $9 million for the costs of the expanded recall. All told, the company expects to spend $23.2 million on the Avaira recalls, according to the press release.

Consumers with problems or questions related to the recalls should contact the company at 1-855-526-6737. The firm says it has reached out to affected consumers to ensure their safety.

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Torn corneas, vision problems follow 'stealth recall' of contact lenses!

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Related News.
(news that follow from above.)


Torn corneas, vision problems follow 'stealth recall' of contact lenses!
Oct.11.2011

Amid growing reports of eye problems ranging from blurry vision to torn corneas, federal health officials are threatening to issue a public warning about recalled contact lenses manufactured by CooperVision Inc. and sold widely at stores such as Costco, Wal-Mart and LensCrafters.

The Fairport, N.Y., firm has yet to heed a request from the federal Food and Drug Administration to broaden notification of problems with certain lots of its Avaira Toric contact lenses, which were recalled quietly in August because of unidentified “residue.” On Tuesday, CooperVision officials said the recall affected about 600,000 contact lenses, or 10 percent of those sold or issued as samples in the United States.

“Absent prompt and adequate communication by CooperVision, the FDA may independently share its concerns about Avaira Toric contact lenses,” FDA spokeswoman Morgan Liscinsky said in an e-mail.

But for at least a dozen consumers who indicated to msnbc.com they have suffered impaired vision, excruciating pain or landed in emergency rooms after wearing the contacts launched in April and recalled in August, such notice is long overdue.

“It is very frustrating that they’re not more vocal about it and that the FDA hasn’t warned more people,” said Mellisa Cotton, 40, of Atlanta, who said she suffered two corneal abrasions this summer after wearing Avaira Toric contact lenses.

“Next to labor, a corneal abrasion is one of the most painful things you can have," said the mother of two.

Dan O’Neil, 0, of Hampton, Va., said his 15-year-old daughter, Erin, had to be rushed to the local ER on Aug. 21 after using Avaira Toric contact lenses from a newly opened box from Wal-Mart.

"I noticed what first looked like a torn piece of contact on her eye," he said. "Upon closer examination, I realized that what I was seeing was Erin's cornea torn and rolled back."

Doctors confirmed a severe tear and the girl was treated with pain medication and antibiotics. Only after she was injured did O'Neil and his wife learn of the recall.

"The ophthalmologist didn't even seem to be aware of it," he said, adding later. “Any time your kid’s vision is affected, you’re going to worry.”

CooperVision Inc. officials issued a voluntary U.S. recall on Aug. 19 of what the company called “a limited number of lots” in the U.S. market. On Aug. 25, the company notified the FDA of the recall, officials said.

CooperVision officials said they initiated the recall after investigating a “small number of unexpected wearer reports of hazy vision and discomfort.”

A notice posted on the company’s website includes a fill-in box where customers can check to see if their lots are affected. However, it does not include a list of retailers or a complete list of affected lots.

Major retailers said they notified their customers quickly about the Avaira Toric recall. About 2,600 Costco customers who bought the lenses were notified on or soon after Aug. 19, said Craig Wilson, vice president for food safety and quality assurance. Wal-Mart notified its optical departments on Aug. 24, said spokeswoman Dianna Gee. A LensCrafters spokeswoman who didn’t want to give her name said the company notified customers immediately through its retail stores.

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

But the company has yet to issue wider notification in the U.S. that the FDA has the authority to seek, but not demand. “We are requesting that the firm issue a broader statement to ensure that users are aware of the recall,” Liscinsky, the FDA spokeswoman, wrote in an e-mail.

CooperVision officials, did not respond to msnbc.com questions about why they had not complied with the FDA request. In a statement, a firm spokeswoman said that the company “has fully cooperated with the FDA and continues to closely monitor the situation and seek advice from FDA during this process." The company's stock, traded as COO, fell on Tuesday.

Critics say that CooperVision has downplayed the recall of hundreds of lots of contact lenses in the United States, exposing vulnerable consumers to ongoing injury.

Phyllis Entis, author of the blog eFoodAlert, which tracks public safety recalls, has been following the Avaira Toric situation since August, documenting what she said “can only be described as a stealth recall.”

The blog includes reports from several consumers who have reported injuries and other problems with Avaira Toric contact lenses from August through October.

They include Deirdre Shapiro, 43, of Villanova, Pa., who said she suffered hazy vision and a scratched cornea that "felt like someone was in there with a sharp instrument stabbing my eye."

She wore the contacts for months, until September, when her doctor finally notified her of the recall.

"Literally, my whole summer, I thought I was going crazy," she said. "I wish I'd known. I would never have put this thing near my eye."
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