Wednesday, October 19, 2011

Silicone Oil Behind Aviara's Recall, Says FDA


AboutLawsuits reports that "Federal regulators say that silicone oil is the cause of problems with Aviara contact lenses sold by CooperVision, which were quietly removed from the market in August after a number of consumers suffered torn corneas, hazy vision and other potentially serious complications....More than 778,000 CooperVision Aviara contact lenses were impacted by the recall, which was not widely publicized until the FDA criticized the company last week for failing to take sufficient steps to make sure consumers were aware of the contact lens problems." Read more.


Here's what CooperVision has to say about the CL and the recall:


"If [a patient wears]...Avaira Toric contact lenses and experience[s] any symptoms, CooperVision recommends that [the patient]... stop wearing the lenses immediately.  Contact your eye care practitioner for advice. If [a patient wears]...Avaira Toric contact lenses and [is]... not experiencing symptoms, CooperVision recommends...:
  • "Go to the CooperVision recall web page at www.coopervision.com/recall, and enter the lot number of [the]... package to determine whether [the]... lenses have been recalled.
  • "Alternatively, ...contact [CooperVision on its}...toll-free consumer hotline (1-855-526-6737).
  • "If ... lenses have been recalled, immediately remove [the]... existing lenses, discontinue lens wear; and return [the]... lenses to [the]... eye care practitioner or point of purchase.
"The recall was initiated because of the unintended presence of a residue on certain lots of Avaira Toric lenses, which may cause hazy vision, discomfort, or eye injuries requiring medical treatment. Not everyone experiences the same symptoms. Since the initiation of the recall, the company has received some additional complaints of severe eye pain. Avaira Toric contact lens wearers that experience any symptoms should stop wearing the lenses immediately and speak with their eye care practitioner. The company has  ongoing relationships with practitioners to continue to identify all the affected lots in the market. To date, the recall has impacted approximately 600,000 Avaira Toric contact lenses in the U.S." Read more.

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