Thursday, December 20, 2012

Alerts about Illegal Eyewear, Sunglasses, and Contact Lenses

By updating Import Alert 86-07, the U.S. Food and Drug Administration (FDA) has 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. Read more.

Here's the beginning of the alert:
 Eyeglasses and sunglasses imported into the United States are required to comply with 21 CFR 801.410, "Use of impact-resistant lenses in eyeglasses and sunglasses". A certificate to comply with 21 CFR 801.410(g) must accompany each entry of eyeglasses and sunglasses showing the lens manufacturer has conducted tests of the lenses using the impact test described in paragraph (d)(2) of 21 CFR 801.410 or any equal or superior test. It has been reported that certificates from foreign manufacturers may not be valid. Tests by one U.S. distributor revealed 40-70% breakage which differed significantly from the manufacturer's certificate. Due to apparent certificate irregularities SAN-DO collected a sample of children's sunglasses. The manufacturer's certificate indicated that no lenses broke during testing. However, WEAC testing of the sample found that nearly every lens broke completely. To read more of the alert, click this link.

Meanwhile, "the Minneapolis office of Homeland Security Investigations is warning consumers about counterfeit products," according to the CBS News affiliate (WCCO) in Minneapolis. "Homeland Security agents showed WCCO a room full of fake products, made to look like the real thing. But on closer examination, it is clear that these items are of extremely poor quality — everything from contact lenses to prescription medication." Read more.

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