FDA Threat Prompts CooperVision to Reannounce Avaira Toric Contact Lens Recall

Pressure from U.S health regulators finally prompted CooperVision Inc. to step up its efforts to get the word out about its recent <"http://www.yourlawyer.com/topics/overview/coopervision-avaira-topic-contact-lens-recall-eye-injury-lawyers">recall of Avaira Toric contact lenses. According to a report from MSNBC, CooperVision is also acknowledging that some users of the recalled contact lenses suffered severe eye pain.

Avaira Toric contact lenses were only put on the market in April 2010. On August 19, CooperVision recalled roughly 600,000 contact lenses in the U.S., ostensibly because of an unidentified residue caused by a manufacturing issue. The U.S. recall was part of a worldwide action that involved 8 million lenses.

At the time, CooperVision said the residue was discovered after some Avaira Toric contact lens users complained of hazy vision. But as we reported previously, many people have reported painful eye injuries, including torn corneas. Some even had to be rushed to emergency rooms. According to the latest MSNBC report, the U.S. Food & Drug Administration’s (FDA) database has received about 15 complaints linked to the lenses, including reports of torn corneas.

CooperVision’s original recall notice focused on sellers of the contacts, including Costco, Wal-Mart and LensCrafters. The FDA wasn’t satisfied with the notification, and had threatened to issue its own public notification of the recall. As MSNBC points out, the FDA only has the power to advise companies about appropriate levels of public notification and other action.

Yesterday, CooperVision finally issued a press release about the Avaira Toric contact lens recall. The release acknowledges that some contact lens users experienced “severe eye pain,” and advises that “not everyone experiences the same symptoms.” It further recommended that affected users seek medical care.

The FDA said yesterday that it was continuing to review CooperVision’s response.

“Failing resolution of those concerns, the FDA may issue a separate public communication,” an agency spokesperson said.

Contact lens users who are unsure whether or not their lenses are included in this recall can:

• Go to the CooperVision recall web page and enter the lot number of your package to see whether your lenses have been recalled.

• Receive information via the toll-free consumer hotline (1-855-526-6737)

Consumers who have the Avaira Toric lenses covered by the recall should return them to their eye care practitioner or place of purchase.

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