Avaira Contact Lens Recall Lawsuit
FDA to inspect CooperVision contact lens plant

The U.S. Food and Drug Administration has notified Cooper Companies that an inspection for quality control and labeling problems  at the firm’s CooperVision Incorporated contact lens plant, located in Henrietta, will be taking place.

A letter was issued to President John Weber of The Cooper Companies citing instances of mislabeled products, discrepancies in packaging inspection procedures, and also failures in documenting inspection findings found by an FDA inspector during a visit which took place in October.

Although CooperVision officials did respond to the FDA’s concerns by setting a schedule for re-examining the cited procedures and training of CooperVision workers, the FDA states that they are unable to determine whether the company’s response is sufficient. A warning was also issued in the letter stating that if the cited problems are not corrected, the company may face fines or other necessary action.

CooperVision Incorporated is the manufacturer of Avaira® contact lenses, which are designed to treat persons diagnosed with astigmatism, nearsightedness, and/or farsightedness. However, the contact lens giant has been facing much turmoil this past year as many victims come forth against the company with claims of injuries caused by Avaira contact lenses.

A voluntary recall on certain lots of Avaira contacts was first issued by CooperVision in August of 2011 after silicone oil residue was shown to contaminate the contact lenses. Approximately 778,000 Avaira Toric contact lenses were affected by the initial recall. In October, the FDA issued a warning letter regarding the risks associated with wear of the contact lenses and advised consumers to return their contact lenses if they were included in the recall or if vision symptoms occurred from wearing Avaira contact lenses.

In November of 2011, the company was forced to expand their recall of Avaira contact lenses to include 5 million of their extended line of lenses, Avaira Sphere.

Both CooperVision and its parent company The Cooper Companies currently face lawsuits. Victims who have worn Avaira contact lenses are suing CooperVision because of eye injuries and stockholders are suing The Cooper Companies for alleged inflation of stock value.




About the Contributor

Related Posts