In mid-October, CooperVision Inc. announced that a counterfeit version of its Proclear Compatibles Sphere contact lenses was found in the U.S. market and was believed to be solely distributed by 1-800 CONTACTS.

CooperVision was made aware of a possible problem in August when the company received phone calls from two patients who complained about the inferior quality of their contact lenses. The two patients also said that they had received the lenses from 1-800 CONTACTS.

CooperVision obtained the lenses from one of the consumers and determined that the lenses were fakes after an in-house analysis. CooperVision says three red flags were raised concerning the packaging. Specifically:

The box was 12.5cm long vs. the current packaging, which is 11.0cm. (However, CooperVision says that not all 12.5cm boxes are counterfeit.)

The box contained a counterfeit lot number. (To view the list of counterfeit lot numbers CooperVision has identified thus far, go to www.coopervision.com/us/patient_aboutus_news.asp?id=22.)

The box had subtle graphical differences that CooperVision says would be recognizable to people who deal with a lot of contact lens packaging.

Upon learning of the fake lenses, CooperVision immediately notified 1-800 CONTACTS and all known unauthorized distributors of Proclear Compatibles about the counterfeit product and asked these distributors to quarantine any inventory of the product, and to contact CooperVision for further instructions.

CooperVision believes the U.S. distribution of the fake product is limited to 1-800 CONTACTS because the giant contact lens retailer is the only source that has been linked to the fake contact lenses thus far.

As a result, both CooperVision and 1-800-CONTACTS are working together in conjunction with the U.S. Food and Drug Administration to watch and correct the problem.

But, this is not the first time CooperVision has come across this issue. In February 2004, the contact lens company says it was made aware of suspicious Proclear Compatibles Sphere contact lenses that had been distributed in France. Subsequent analysis of these lenses showed them to be of inferior quality and, in some cases, they were contaminated with Pseudomonas bacteria or were non-sterile.

After these discoveries were made, CooperVision says it took steps to both trace the source of the counterfeit product and to preclude the fake lenses from entering the United States.

Thus far, however, CooperVision has been unsuccessful in locating the distributor.

The contact lens company has also been unsuccessful in unmasking the distributor of the recent counterfeit lens.

When the counterfeit product surfaced in the U.S., the only reference we had of a previous counterfeit product was the one within the French market, but were not saying the two cases are related, says Jeff McLean CooperVisions vice president of sales.

Kevin McCallum, a corporate spokesman for 1-800 CONTACTS, says the contact lens retailer believes the counterfeit contact lens problem occurred because of CooperVisions restricted distribution policy. Since [CooperVision] doesnt sell those lenses to us directly, were forced to buy those lenses through distributors, and thats what opens up a problem like this, he says.

Mr. McCallum adds that 1-800 CONTACTS has thus far shipped more than 250 million lenses in its history, and that this is the first time the company has ever had to notify a customer of a potential health issue with their lenses.

Were taking a very proactive approach with the handful of customers who were possibly affected, and we have sent voluntary recall letters to any Proclear customer who may have possibly been affected, he says. 

CooperVision, meanwhile, urges all U.S. practitioners who have suspicious packaging that contains these lenses, or who have a patient or patients with complaints related to the Proclear Compatibles Sphere, to contact CooperVisions customer service line (1-800-538-7850). The company will exchange the product free-of-charge and cover any shipping and handling fees.
We have a policy that if any U.S. practitioner has any concerns, or the patient has any concerns, well take care of those on a case-by-case basis to make sure that the patient is refit with a legitimate Proclear Product, says Mr. McLean.