Detention Without Physical Examination of and Guidance for *** Impact-Resistant Lenses in Eyeglasses and Sunglasses ***

*** 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.

*** More recently, SAN-DO collected a sample of adult prescription lenses. WEAC testing of the sample found that 38% of the lenses broke completely. ***

*** Districts may detain without physical examination all impact-resistant lenses in eyeglasses and sunglasses from the manufacturers listed in the attachment to this alert. Manufacturers listed in the attachment to this Import Alert have had their impact-resistant lenses in eyeglasses and sunglasses analyzed and were found to not be in accordance with 21 CFR 801.410. (Use OASIS Charge Code NOT IMPACT)

Districts may detain any impact-resistant lenses in eyeglasses and sunglasses which are analyzed and found to not be in accordance with 21 CFR 801.410. (Use OASIS Charge Code NOT IMPACT)

A recommendation for detention without physical examination and background information, including analytical worksheets, should be forwarded to DIOP, HFC-170. DIOP will coordinate with CDRH for concurrence.

Districts may detain any entries of impact-resistant lenses in eyeglasses and sunglasses which are not accompanied by a batch certificate showing compliance with 21 CFR 801.410(g). Any certificate submitted should show the lenses meet an AQL of 6.5 when tested by the drop ball test or an equal or superior test method; impact-resistant lenses in eyeglasses and sunglasses are subject to refusal of admission for failure to meet the AQL of 6.5 or failure to conduct the drop ball testing. (Use OASIS Charge Code LENS CERT)

NOTE: Firms are not to be added to the attachment to this Import Alert solely for failure to provide batch certificates.

Surveillance of all impact-resistant lenses in eyeglasses and sunglasses from all countries is warranted.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

For guidance on removal from detention without physical examination, refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."

If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
ELEM 3109
Rockville Md, 20857

Or via email: Importalerts2@fda.hhs.gov ***


RECOMMENDING
OFFICE: *** SAN-DO, HFR-PA150 ***
*** CDRH, HFZ-330 ***

*** IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES ***

"The article¿s strength differs from, or its purity or quality falls below that which it purports or is represented to possess, in that it appears to not have impact-resistant lenses in accordance with 21 CFR 801.410. [Adulteration, section 501(c), 801(a)(3)]"

OASIS Charge Code: NOT IMPACT

and/or

"If its labeling is false or misleading in any particular, in that the lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but do not appear to be impact-resistant or such required certificate is not provided. [Misbranding, section 502(a), 801(a)(3)]"

OASIS Charge Code: LENS CERT