23 Sept 2016
On-line Retailer Pleads Guilty to Importing Counterfeit Contact Lenses from Mainland China
The U.S. Department of Justice announced on 9 September that the owner and operator of an on-line retailer has pleaded guilty to running an international operation involving imports of counterfeit and misbranded contact lenses from mainland China and South Korea. The DOJ notes that a substantial part of this fraudulent scheme was committed from outside the United States and yielded at least US$1.2 million in gross revenue.
All contact lenses are medical devices that must receive FDA authorisation to enter and be further distributed in the United States, a DOJ press release states, but the man admitted to importing large quantities of coloured contact lenses from mainland China and South Korea that he knew were counterfeit and/or unauthorised by the FDA for sale in the United States. Many of these lenses bore labels with counterfeit trademarks, while others had labels of brands of contact lenses produced and sold in Asia. The man then sold these counterfeit contact lenses to tens of thousands of customers around the United States without a prescription, adequate directions for use, or adequate warnings. The man admitted that some of these lenses were tested and found to be contaminated with potentially hazardous bacteria.