A Class 1 Recall Unintended Residue on Lenses
There has been a Class 1 Avaira contact lenses recall. The FDA has issued a recall on Avaira® Toric contact lenses which may have affected over 778,301 people nationwide.
The Avaira® Toric Lenses are now considered by the FDA to be a Class I Recall. A FDA Class 1 recall denotes the most critical type of recall. These recalls are ones in which the FDA has determine there is a probability that the product may cause serious health issues or death with use. The specific lenses are AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism.
Why is an Avaira contact lenses recall necessary? More than 8 million lenses are affected by the problems, according to the FDA, though it is estimated only 600,000 made it onto the U.S. market. There may be more lenses recalled made by the manufacturer CooperVision Inc. as our investigation continues. Manufacturing of these lenses occurred between November 2010 and early August 2011.
In addition, on November 16, 2011, CooperVision, the manufacturer of these lenses, widened its Avaira contact lenses recall to encompass some additional lots of Avaira Sphere contact lenses. They have stated that CooperVision has identified specific Avaira Sphere lenses which have not achieved their quality requirements. Furthermore, they have acknowledged tthe Avaira contact lenses recall is the result of a silicone oil residue.
Avaira Sphere contact lenses may cause blurred vision, eye pain or eye problems which may require treatment from a medical doctor. Not everyone experiences the same symptoms.
It has been determined that there is a silicone residue on these Avaira contact lenses. Reported symptoms are hazy or blurry vision, discomfort to eyes or injuries requiring medical treatment. According to MSNBC, additional investigation by the news affiliate has revealed users have also suffered severe injuries such as torn corneas, vision problems follow the ‘stealth recall’ of contact lenses.
Click here for the FDA CooperVision AVAIRA Toric and Sphere Soft Contact Lenses notice.
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For more information about the Avaira contact lenses recall please contact Bernheim & Dolinsky, L.L.C. at 1-800-474-4089 or contact us online.
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