CooperVision Adds 6 Million Avaira Sphere Lenses to Contact Lens Recall

CooperVision Inc. is expanding its recent contact lens recall to include to an additional brand. With the expansion, the <"">CooperVision contact lens recall now includes an additional 6 million lenses sold under the Avaira Sphere brand name.

In October, the U.S. Food & Drug Administration (FDA) issued a Class I recall – its most serious recall action – for more than 778,000 Avaira Toric lenses. The recall was issued because of a silicone oil residue that could cause users to suffer problems ranging from hazy, blurry vision and discomfort to eye injuries, such as torn corneas and corneal abrasions, that often required medical treatment.

According to a new report from MSNBC, the expanded recall includes 6.6 million Avaira Sphere lenses. However, only 4.9 million of the recalled contact lenses were actually shipped to consumers, according to CooperVision. In a statement, CooperVision said it was expanding the recall because it identified certain lots of Avaira Sphere lenses that did not meet its updated quality requirements due to the level of a silicone oil residue.

Thus far, the FDA has received 40 reports of problems associated with various CooperVision contact lenses, according to MSNBC. Of those, at least 15 mentioned Avaira Toric and at least two mentioned Avaira Sphere.

When the original Avaira Toric CooperVision recall first came to light in October, the company was criticized for issuing in August what some referred to as a “stealth” recall. CooperVision had only issued the original notification letter to U.S. and Canadian distributors and health care practitioners who sold the lenses, and some users complained they never heard about the recall prior to experiencing a problem. In October, however, the FDA pressured the company to widen its recall notification.

In today’s recall notice, CooperVision advised Avaira Sphere contact lens users to stop wearing them if they experience eye problems, and seek medical attention. CooperVision is also launching a website for wearers to enter the package lot number found on the contact lens carton or blister label to determine if their lenses have been recalled. Lens wearers can also contact CooperVision on a toll-free consumer hotline at 1-855-526-6737. Anyone with lenses included in the recall should return them to the point of purchase or to their eye care practitioner.

CooperVision said no product lines other than Avaira Toric and Avaira Sphere are affected by the recall, as none of its other lens lines involve the use of silicone oil to manufacture the products.

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