The FDA has announced a Class 1 recall for AVAIRA Toric (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. The contact lenses subject to the recall were manufactured from November 1, 2010 through August 3, 2011. About 778,301 of the affected contact lenses are subject to the recall.
The reason for the recall is that there may be an unintended presence of a silicone oil residue on the lenses from certain lots of Avaira Toric contact lenses. Medical treatment may be required for symptoms that range from hazy, blurry vision, to discomfort or eye injuries.
The Avaira Toric soft contact lenses are used to correct for nearsightedness or farsightedness with astigmatism. They are intended for single-use disposable wear and daily wear. They were manufactured by CooperVision, Inc., which is located in W. Henrietta, New York. CooperVision has set up a website for more information regarding the recall: www.coopervision.com/recall. By entering the package lot number on the website, consumers can determine if their lenses are part of the recall.
The original recall was announced on August 19, 2011. CooperVision posted an update regarding the recall on October 13, 2011.
CooperVision reported that not everyone experiences the same problems but it has received some complaints of severe eye pain since the recall was first announced. CooperVision stated that the recall affected about 600,000 Avaira Toric contact lenses in the United States and that it had sent recall notifications to more than 9,000 Avaira Toric contact lense customers worldwide in the first two weeks after the August 19, 2011 recall was announced. CooperVision also stated that it had contacted more than 7,000 eye care practitioners in the United States who had received or sampled the lenses. CooperVision said that its distributors were instructed to return all (not just specific lot numbers) of Avaira Toric products.
While the reported efforts of CooperVision with regard to the recall of its Avaira Toric contact lenses appear to be be genuine and authentic, we are concerned that the lenses subject to the recall were able to enter the consumer products stream in the United States before the problems with the lenses were identified and corrected. Our eyes and our eyesight are irreplaceable. We rely on the manufacturers of eye care products to establish and ensure appropriate manufacturing and quality control techniques to prevent defective products from entering the stream of commerce. Once someone is injured as a result of a defective product, recall efforts are useless for that person.
If you have been injured as a result of a defective medical device (contact lenses are medical devices as well as other consumer products that many people may not realize are classified as such), you may be entitled to compensation for your injuries and losses. Many medical malpractice lawyers also handle claims involving defective or dangerous medical devices and drugs.
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