Nearly two months after problems were first announced, contact lens giant CooperVision Inc. and federal health regulators have amped up public warnings about nearly 780,000 recalled contact lenses, urging users to return the potentially defective products and to seek medical care if they show symptoms of harm.
The federal Food and Drug Administration on Friday posted a Class I recall warning about CooperVision's Avaira Toric contact lenses, which were first recalled Aug. 19 because of residue left behind during manufacturing. In a safety alert, the FDA identified the substance as a silicone oil residue.
Class I recalls are the most serious kind of recall and involve problems in which there is a reasonable chance of serious adverse health consequences or death.
“If your lenses have been recalled, immediately remove your existing lenses, discontinue lens wear and return your lenses to your eye care practitioner or point of purchase,” CooperVision officials wrote in a statement posted Friday on the FDA's website.
Consumers have reported problems with hazy vision, discomfort, severe pain and eye injuries requiring medical treatment, the release said.
The notice comes after FDA officials demanded that the Fairport, N.Y., firm broaden its notification of the recall of Avaira Toric lenses manufactured from Nov. 1, 2010 to Aug. 3. The FDA now says some 778,301 lenses were distributed. CooperVision officials originally said about 600,000 lenses were affected.
FDA officials had threatened to issue independent notice of concerns about the contact lenses if CooperVision didn’t adequately publicize the potential for problems caused by unidentified and unintended residue left behind during manufacturing.
"CooperVision's public communications are consistent with the agency's expectations for a Class I recall," Morgan Liscinsky, an FDA spokeswoman, said in an e-mail Friday."The FDA will continue to monitor this recall's effectiveness to ensure that the affected devices are moved from the marketplace and not used by consumers."
CooperVision had issued what Phyllis Entis, author of the blog eFoodAlert, called a “stealth recall” of the products in the United States after issuing more detailed recalls in several other countries, including Australia, Hong Kong and Spain. Entis first raised concerns in August, when she started receiving reports of serious eye injuries tied to the Avaira Toric lenses.
"In my opinion, CooperVision is engaging in damage control, now that their problem is no longer stealthy," Entis said.
The early release said that consumers experienced only hazy vision and discomfort.
Since then, Entis said dozens of consumers have reported problems ranging from blurry vision and eye irritation to corneal abrasions and tears that required emergency department visits. Some reports involved CooperVision brands other than Avaira Toric, but FDA officials said no other brands have been recalled.
Most of the users said they were not notified by the retailers who sold the products, including Costco, Walmart and LensCrafters about the recall. Nor were they told about the potential for injuries by their eye care providers. Some consumers said they intend to sue CooperVision for financial and medical harm blamed on the recalled lenses.
FDA officials had received at least 15 reports of injuries related to the recalled lenses, including severe injuries such as corneal tears, said Liscinsky, the FDA spokeswoman.
Consumers can check to see if their contact lenses are affected by the recall at www.coopervision.com/recall. Or they can call a toll-free consumer hotline at 1-855-526-6737 for more information.