editor's perspective
Are You Selling Your Patients the Real Thing?

Recently, at least one U.S. contact lens manufacturer first became aware of counterfeit lenses after receiving an unusual number of complaints about irritation with one brand of its soft lenses in France. On further inspection, the manufacturer found that the lenses in question were not consistent with the package labeling and were not made by this manufacturer. After tracing the product back to the source of distribution (a French distributor of contact lenses), the manufacturer found that this distributor bought the lenses from a grey market distributor, not from the manufacturer. It also determined that the lenses were not sterile in addition to being mislabeled. This situation could have been down right dangerous. Fortunately, it's now under control and the counterfeit lenses caused no irreversible harm.

Some practitioners or distributors buy lenses and sell them to other people, distributors or mail-order/Internet companies in an unauthorized scheme, but at least this grey market activity results in the real, true, authentic contact lenses in patients' hands. But, in the scheme I mentioned above, the lenses were probably made clandestinely in an unregulated factory in a far off land. The lenses weren't sterile and were mislabeled.

It's never occurred to me that a lens I provided to a patient was a fake. It will now. You may wonder if U.S. distributors would consider certifying that the products they distribute are authentic. You may further wonder if mail-order and Internet firms will guarantee that the products they supply are authentic -- especially with the new required prescription release legislation in effect.

Just this past month, CooperVision uncovered counterfeit Proclear Compatibles in the U.S. market. The company became aware of the problem after two patients complained to CooperVision about the quality of their lenses. One of the patients returned the suspect lenses to the company, and subsequent analysis determined they were counterfeit and even contaminated. CooperVision believes the product to have come from 1-800 Contacts, and both CooperVision and 1-800 are working with the FDA to monitor and correct the situation.

It seems we need to monitor the packaging of lenses carefully and tell our patients to do the same.