CooperVision, Inc., the manufacturer of several brands of contact lenses, has recalled 5 million contact lenses shipped to customers during 2011. The first recall involved contacts sold under the Avaira Toric brand name. This recall, which was initiated in October 2011, affected nearly 780,000 leanses. The second recall, announced November 8, 2011, expanded the recall to include Avaira Sphere lenses, and affected the users of another 4.9 contact lenses.
These major recalls follow dozens of injury reports submitted to the Food and Drug Administration over the past year, including torn corneas, hazy or blurred vision, and severe eye pain. In response to these injury reports, he FDA issued a Class I warning on the Avaira contact lenses, the most serious warning allowed under the FDA regulations. The injuries are thought to stem from the use of silicone oil in the manufacturing process. CooperVision is the only manufacturer known to use silicone oil in the manufacture of its lenses.
Of the reported injuries where the brand of lens was known, the majority involved the users of Avaira Toric. The Toric lenses are marketed by CooperVision with claims that their unique material can actually “bind water within the lens without the need for additional surface treatments or wetting agents.” CooperVision also claims that these lenses are softer and more flexible that other brands of contacts. In making the recall, CooperVision admitted that the recalled lots did not meet the company’s “updated quality requirements due to the level of . . . silicone oil.” The company also admitted that in some cases, the initial injury report was limited to hazy vision, but the injury progressed and severe pain and other eye injuries developed.
Although CooperVision denies that any of the injury reports involved permanent injuries, this claim seems contradictory to the FDA’s decision to issue the Class I warning, which is normally reserved for drugs and medical products that have caused serious injury or death. Once additional information is released on the injury reports, our Avaira lawyers will work to confirm the claims made by the manufacturer of these dangerous contact lenses.