CooperVision has recalled certain lots of its Avaira Sphere brand contact lenses because it was found that they were distributed with dangerous silicone residue. The U.S. Food & Drug Administration (FDA) has received numerous reports of severe eye pain, discomfort, and even torn corneas associated with Avaira Sphere contacts. Although not all users will experience the same symptoms, the level of silicone residue in the recalled lots may cause some patients to suffer lifelong eye injuries.
What’s the problem?
On December 7, 2011, the Department of Consumer Protection (DCP) announced that CooperVision’s October-issued nationwide recall of Avaira contact lenses was being expanded to include certain lots of Aquaform Sphere contacts as well. Manufactured between February 1 and August 24, 2011, these lenses were distributed to retailers around the country from March 2 through November 15, 2011.
This medical device recall also included an expansion of the August recall for limited lots of Avaira Toric contact lenses. CooperVision stated that the problem with this line of contacts has been corrected through its quality system process.
CooperVision Avaira Sphere contact lenses are intended for the correction of myopia or hyperopia in aphakic and non-aphakic patients with non-diseased eyes. Additionally, the contacts may be worn by individuals who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual activity.
CooperVision Avaira Sphere Contact Lens Side Effects
Symptoms caused by the silicone residue on the contact lenses may include (but are not limited to):
- torn corneas
- corneal abrasion
- blurry vision
- impaired vision
- severe eye pain
- loss of vision
Contact lens injuries occur quite frequently due to product defect or improper use. Injuries of this type are most common among children and adolescents. A recent study published in the medical journal Pediatrics found that nearly 25% of all medical device injuries in 2004 and 2005 involved children and contact lenses. Children ages 11 and over were the most affected age category.
If you believe you may have worn CooperVision Avaira Sphere contact lenses included in this recall, you should stop using them immediately and contact your eye care practitioner for advice. Avaira Sphere contact lens wearers should check CooperVision’s recall website to enter the lot number found on the packaging to determine if their lenses have been recalled. You may also contact the company’s toll-free customer hotline at 1-855-526-6737. Keep all contact lenses, including packaging and boxes, in a safe place. Do not return the contacts to the retailer or your eye care professional, because your individual contact lenses are the best proof of the cause of your injuries.
Class I FDA recalls are reserved for dangerous or defective products that could potentially cause serious health problems or even death. Examples of products classified in this category include label mix-ups on prescription medications, food found to contain bacterial pathogens, and defective artificial heart valves.
New CooperVision Contact Lens Lawsuit Filed in California
On November 28, 2011, a Connecticut law firm filed a legal claim against Cooper Cos. over its recall of Avaira contact lenses. The suit, which was filed in U.S. District Court for the Northern District of California, alleges that the company downplayed the problems it was having with the Avaira line and thus artificially inflated its stock, causing investors huge losses when the real problems came to the public’s attention. The claim is seeking class action status to represent any investor who purchased Cooper stock between March 4 and November 15, 2011.
In the days leading up to the first recall in August, Cooper shares were trading for around $70 apiece. The stock temporarily fell to less than $67 for several days before rebounding. But since November 15, Cooper shares have been trading for well below $60.
According to the complaint, Cooper executives including CEO Robert S. Weiss and CFO Eugene J. Midlock, made millions of dollars by cashing in a portion of their shares despite the fact that they were “… personally familiar with Cooper’s growing quality control problems” with the Avaira line of contact lenses. Yet at the same time, Cooper was downplaying the August recall by boosting stated expectations for its 2011 revenues. The lawsuit is seeking unspecified damages.