Import Alert 86-07

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 86-07
Published Date: 05/04/2018
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF AND GUIDANCE FOR IMPACT-RESISTANT LENSES IN EYEGLASSES AND SUNGLASSES

Reason for Alert:

NOTE: The revisions to this import alert dated 10/27/2014 replaces DIOP with DIO, updates the CDRH Import Branch name and contact information, updates contact information for the Office of Regulatory Science and provides additional information on the removal process. Changes are bracketed by asterisks (***).

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.

Guidance:

*** Districts may detain, without physical sampling and analysis, products from the manufacturers identified in the Red List for this import alert. Manufacturers listed in the Red List 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. ***

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.

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

A recommendation for detention without physical examination and background information, including analytical worksheets, should be forwarded to *** DIO, Import Operations and Maintenance Branch, HFC-172. ***

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.

*** For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301-796-6600.

For questions concerning these types of products or other compliance issues, contact CDRH/OC Imports Branch, 301-796-5500, or email: cdrhocimport@fda.hhs.gov.

For questions or issues involving import operations, contact the Division of Import Operations at (301) 796-0356, or email fdaimportsinquiry@fda.hhs.gov.

For guidance on removal from detention without physical examination, refer to FDA's 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
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

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

Product Description:

Impact-Resistant Lenses in Eyeglasses and Sunglasses

Charge:

"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

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (86 H - - QG) Lens, Spectacle, Non-Custom (Prescription)
    Desc: for reading glasses and spectable; non-custom Rx
  • (86 H - - QY) Sunglasses (Non-Prescription Including Photosensitive)
    Desc: Sunglasses
  • (86 N - - JH) Lens, Spectacle (Prescription), for Reading Discomfort
    Desc: for lens; spectacle Rx for reading discomfort

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CHINA


COOMEX SOURCE LIMITED
Date Published : 08/26/2010
Add-Rm 1606, Guagfa Mansion , # 42 Qingdaozhonglu; Shinan , Qingdao, Shandong CHINA
86 H - - LN Gauge, Lens, Ophthalmic
Date Published: 08/26/2010

Desc: for Gauge; Lens; Spectacle

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 08/26/2010

Desc: for sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 08/26/2010

Desc: for reading glasses and spectacle; non-custom Rx

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 08/26/2010

Desc: for Lens; spectacle rx for reading discomfort

DANYANG SAN-SINO OPTICAL CO., LTD.
Date Published : 08/26/2010
GLASSES INDUSTRIAL PARK , Zhenjiangshi, Jiangsusheng CHINA
86 H - - LN Gauge, Lens, Ophthalmic
Date Published: 08/26/2010

Desc: for Gauge; Lens; Spectacle

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 08/26/2010

Desc: for reading glasses and Spectacle; Non-custom Rx

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 08/26/2010

Desc: for sunglasses

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 08/26/2010

Desc: for Lens; Spectacle Rx for reading discomfort

DONGGUAN MEIAOQI
Date Published : 03/08/2017
76 Baijia Road Qingxi T , Dongguan City, CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/08/2017

Desc: Sunglasses

Glory International Trading Inc
Date Published : 06/27/2011
No.81 Daqing Road, Advanced Technology , Tangsh, CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 06/27/2011

Desc: Plastic Sunglasses

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 06/27/2011

Desc: Plastic Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 06/27/2011

Desc: Plastic Sunglasses

Guangzhou Universal Optical Products Co., Ltd.
Date Published : 12/20/2011
No. 2 Industry Area, Lion Hill Town , Huandu Area Guangzhou, CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 12/20/2011

Desc: Plastic Sunglasses

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 12/20/2011

Desc: Plastic Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 12/20/2011

Desc: Plastic Sunglasses

JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD.
Date Published : 04/20/2015
Zone Lutianjizhen , Po Yang County , Shangraoshi, Jiangxisheng CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 04/20/2015

Desc: Sunglasses

LINHAI CITY ZHENXIAN GLASSES FACTORY
Date Published : 02/02/2015
Dafen Industrial Zone , Duqiao, Linhai , Taizhou, Zhejiang CHINA
86 H - - NC Specula, Ophthalmic
Date Published: 03/10/2015

Desc: Sunglasses

86 H - - OI Spectacle, Magnifying
Date Published: 03/10/2015

Desc: Sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 03/10/2015

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 02/02/2015

Desc: Sunglasses

Linhai Botao Glasses Co Ltd
Date Published : 11/29/2013
Lujia Village Dugqiao Town , Linhai, CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 11/29/2013

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 11/29/2013

Desc: Sunglasses

Linhai City Qianbaidu Glasses Factory
Date Published : 07/19/2012
Xiabanian Cun , Linhai , Taizhou, Zhejiang CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 07/19/2012

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 07/19/2012

Desc: Sunglasses

Linhai Industrial Glasses Factory
Date Published : 10/11/2013
Duchuan 387 The Road , Linhai City, CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 10/11/2013

Desc: Sunglasses

Linhai Xuanhong Glasses Factory
Date Published : 08/28/2017
Yangping Village , Duqiao Town , Linhai, Zhejiang CHINA
86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 08/28/2017

Desc: Sunglasses
Notes: 4/4/2014

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 08/28/2017

Desc: Sunglasses
Notes: 4/4/2014

San Ho Hasts
Date Published : 02/02/2015
Mulun Changping , Dongguan, CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 02/02/2015

Desc: Sunglasses

See-Good Enterprise Co., Ltd
Date Published : 01/23/2014
East 2, Yixingcun, Qixi Road , Huang Qi, Nanhai, Foshan City , Guangdong, CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 01/23/2014

Desc: Sunglasses

Sunfree Enterprise Co Ltd
Date Published : 05/03/2011
2nd Industrial Estate Shi-Ling , Guangzhou, CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

TAIZHOU PINXIN GLASSES CO., LTD
Date Published : 05/04/2018
Funan , XI Zhicun; Linhai , Taizhou, Zhejiang CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/04/2018

Desc: Sunglasses

86 H - - QZ Frame, Spectacle
Date Published: 05/04/2018

Desc: Sunglasses

TAIZHOU WEIFENG GLASSES CO., LTD.
Date Published : 10/31/2011
Du North Rd , Linhai , Taizhou, Zhejiang CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 10/31/2011

Desc: Sunglasses

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 10/31/2011

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 10/31/2011

Desc: Sunglasses

Taizhou Hongfa Glasses Co., Ltd.
Date Published : 07/01/2016
Duqiao Taizhou , Taizhou, Zhejiang CHINA
86 H - - NC Specula, Ophthalmic
Date Published: 07/01/2016

Desc: Sunglasses

86 H - - OI Spectacle, Magnifying
Date Published: 07/01/2016

Desc: Reading Glasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 07/01/2016

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 07/01/2016

Desc: Sunglasses

86 H - - QZ Frame, Spectacle
Date Published: 07/01/2016

Desc: Reading Glasses

Tazhou Meidiya Glasses Co., Ltd.
Date Published : 06/24/2014
Haiwanlangqin Building NO. 191 , Taizhou, CHINA
86 H - - NC Specula, Ophthalmic
Date Published: 06/24/2014

Desc: Sunglasses

86 H - - OI Spectacle, Magnifying
Date Published: 06/24/2014

Desc: Sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 06/24/2014

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 06/24/2014

Desc: Sunglasses

Tzong Rong Optical Co., Ltd.
Date Published : 05/03/2011
Industry Development Area, , 107 Country Road, West, Shihling Town , Hua-du City Guangdong, Guangdong CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/03/2011

Desc: Gold Steampunk Monacle

Wenzhou N & A Foreign Trade Corp.
Date Published : 03/11/2015
International Trade Center Bldg. F/16 , 8 Liming Rd., West , Wenzhou, Zhejiang CHINA
86 H - - NC Specula, Ophthalmic
Date Published: 03/11/2015

Desc: Sunglasses

86 H - - OI Spectacle, Magnifying
Date Published: 03/11/2015

Desc: Sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 03/11/2015

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/11/2015

Desc: Sunglasses

Wenzhou Ouhua Foreign Trade Corp.
Date Published : 09/22/2010
Block A F/2 , Xiao South Rd; Yongjiaxian , Wenzhou, Zhejiang CHINA
86 H - - LN Gauge, Lens, Ophthalmic
Date Published: 09/22/2010

Desc: for Gauge; Lens; Spectacle
Notes: All eyeglasses/sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 09/22/2010

Desc: for reading glasses and Spectacle; Non-Custom Rx
Notes: All eyeglasses/sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 09/22/2010

Desc: for sunglasses
Notes: All eyeglasses/sunglasses

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 09/22/2010

Desc: for lens; spectacle Rx for reading discomfort
Notes: All eyeglasses/sunglasses

Yh Optics Int Ltd
Date Published : 10/23/2012
Prowin Commercial Centre , Xiegang Town, CHINA
86 H - - OI Spectacle, Magnifying
Date Published: 10/23/2012

Desc: Optical Glass Lenses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 10/23/2012

Desc: Optical Glass Lenses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 10/23/2012

Desc: Optical Glass Lenses


TAIWAN


Co-World Technology Co. Ltd.
Date Published : 05/28/2014
No. 30-2 Zhonglun , Anding District , Tainan City, TAIWAN
86 H - - NC Specula, Ophthalmic
Date Published: 05/28/2014

Desc: Sunglasses

86 H - - OI Spectacle, Magnifying
Date Published: 05/28/2014

Desc: Sunglasses

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 05/28/2014

Desc: Sunglasses

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 05/28/2014

Desc: Sunglasses

Dots Eyewear Inc.
Date Published : 07/07/2016
NO. 120 Zhongzheng 2nd St. , Yongkang Dist. , Tainan City, TAIWAN
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 07/07/2016

Desc: Sunglasses

Hang Chow Industrial Co Ltd
Date Published : 07/15/2010
9f 253 Chungsiao E Rd Sec 3 , Taipei, TAIWAN
86 H - - LN Gauge, Lens, Ophthalmic
Date Published: 08/26/2010

Desc: for Gauge; Lens; Spectacle

86 H - - QG Lens, Spectacle, Non-Custom (Prescription)
Date Published: 08/26/2010

Desc: for reading glasses and spectacle; non-custom rx

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 07/15/2010

86 N - - JH Lens, Spectacle (Prescription), for Reading Discomfort
Date Published: 08/26/2010

Koadak Optical Ind Co.,Ltd
Date Published : 04/20/2015
Taipei World Trade Center 4b-12 , No.5 Sec 5 Hsin Yi Rd,, TAIWAN
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 04/20/2015

Desc: Sunglasses