Reports of eye injuries and severe eye pain have led to a Class 1 recall of CooperVision Avaira Toric and Avaira Sphere contact lenses. Class 1 recalls are the most serious type of recall the Food and Drug Administration (FDA) can issue and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The lenses are used for the correction of nearsightedness or farsightedness, with or without astigmatism, and are indicated for single-use disposable wear and daily wear. When prescribed for frequent replacement, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

The affected Avaira Toric Soft Contact Lenses were manufactured from Nov. 1, 2010 through August 3, 2011. The recalled Avaira Sphere Soft Contact Lenses were manufactured from February 1, 2011 through August 24, 2011, and distributed from March 2, 2011 through November 15, 2011. More than 750,000 lenses are affected by the recall.

Incidence reports vary and included hazy vision, discomfort, eye pain or eye injuries, some of which required medical treatment. CooperVision tested its lenses and found the unintended presence of a silicone oil residue on certain Avaria lenses.

Consumers who have Avaria lenses should go to the CooperVision recall web page at www.CooperVision.com/Internationa-recall and enter the package not number to determine whether the lenses have been recalled. Or, consumers may call the toll-free consumer hotline at 1-855-526-6737.

Source: FDA