FDA issues import alert for substandard, foreign-made eyeglass and sunglass lenses

December 19, 2012

In response to the AOA’s agency outreach and ongoing efforts to improve patient safety, the U.S. Food and Drug Administration (FDA) issued an updated alert authorizing significant enforcement action against several foreign makers of substandard and hazardous eyeglass and sunglass lenses.

On Oct. 23, the FDA issued an official update to Import Alert 86-07 providing renewed authority for federal officials to detain without physical examination substandard eyeglass and sunglass lenses manufactured in and shipped from foreign countries, primarily lenses produced in China.

Under current law, eyeglasses and sunglasses imported into the United States must comply with strict impact resistance requirements.

A certificate must accompany all imported eyeglasses and sunglasses showing that the lens manufacturer has conducted the required impact resistance tests.

The FDA alert asserts that certificates from manufacturers may not be valid and that some foreign lenses may not meet federal standards.

The FDA notes that tests by one U.S. distributor showed a 40 to 70 percent rate of breakage, which differed significantly from the manufacturer’s certificate.

After noticing a number of certificate irregularities, inspectors recently collected a sample of children’s sunglasses from a foreign manufacturer.

The company’s certificate indicated that no lenses broke during testing.

However, independent testing of the sample found that nearly every lens broke completely.

More recently, inspectors collected a sample of adult prescription lenses and found that 37 percent broke completely.

Overall, lenses, readers, and sunglasses must meet an acceptable quality level (AQL) of 6.5 when tested via the drop ball test.

Manufacturers must attest to meeting these U.S. standards through a certificate.

Firms named in the FDA alert include Pilot Optics Corp., Ltd.; Sunfree Enterprise Co., Ltd.; Glory International Trading, Inc.; Guangzhou Universal Optical Products Co., Ltd.; Yh Optics Int., Ltd.; Danyang San-Sino Optical Co., Ltd.; Wenzhou Ouhua Foreign Trade Corp.; and a handful of others.

Until further notice, all shipments from companies named in Import Alert 86-07 will be detained automatically by the FDA.

Even though the alert mentions specific companies, the FDA assures that “surveillance of impact-resistant lenses in eyeglasses and sunglasses from all countries is warranted.”

For its part, the AOA will continue working with FDA and other federal officials to better ensure patient safety.
For the complete list of firms targeted, read the full FDA alert at www.accessdata.fda.gov/cms_ia/importalert_237.html.

To learn more about this important issue or to report a problem or concern, contact the AOA Washington office at ImpactWashingtonDC@aoa.org or 800-365-2219.

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