Vision Council Reports FDA Adds New Optical Factory to ‘Red List’

ALEXANDRIA, VA.— The Vision Council has reported to its member companies that the Food and Drug Administration (FDA) has updated its Import Alert 86-07 list, also known as the "Red List," which identifies companies that are subject to "Detention without Physical Examination" relating to the import of impact-resistant lenses in eyeglasses and sunglasses. The FDA has added Linhai Industrial Glasses Factory, Duchuan 387 The Road, Linhai City, to the list.

The FDA sampled several shipments from all the foreign manufacturers on the list, subjecting them to the impact-resistance test (the drop ball test), and concluded that the tested lenses failed. In turn, because these shipments were accompanied by impact resistance certificates stating that the lenses passed the drop ball test, the FDA considers them misbranded and adulterated merchandise, the Vision Council notice said.

As a result, all shipments from the companies on the list will be detained automatically by the FDA, and those manufacturers will only be removed from the detention list if information is provided to the FDA to adequately demonstrate that the manufacturer has corrected the problem so that the FDA can be assured that future entries will comply with the drop ball test.

For a full list of companies on the Red List and for more information on the FDA’s policy regarding the alert click here.