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: 05/11/2022
Type: DWPE

Import Alert Name:

Detention Without Physical Examination Of Impact-Resistant Lenses In Eyeglasses And Sunglasses

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 05/11/2022 updates the name of the alert, subtype from country wide to firm alert, reason for alert, guidance section, agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***).

*** Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410.

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.***

Guidance:

*** Divisions may detain, without physical examination, products from firms identified in the Red List for this import alert. Firms 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.

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.

Recommendations for additions to the Red List of this import alert will be evaluated by the Division of Import Operations (DIO) and the Center for Devices and Radiological Health (CDRH).

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide documentation which establishes that the appearance of a violation has been removed, such as the Certification Statement of Impact Resistance and/or test results demonstrating that each shipment is in compliance with 21 CFR 801.410.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

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

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

Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at oraorsprivatelabimportalerts@fda.hhs.gov

Questions concerning these types of products or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov

                                                                                                                                                                        ***

Product Description:

Impact-Resistant Lenses in Eyeglasses and Sunglasses

Charge:

***The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410. [Adulteration, section 501(c)]

OASIS Charge Code: NOT IMPACT

AND/OR

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-
resistant. [Misbranding, section 502(a)]

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 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/04/2022

Desc: sunglasses

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

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
Po Yang County , Zone Lutianjizhen , Shangrao, Jiangxi 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
Lujiacun , Linhai , Taizhou, Zhejiang 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

MEIAOQI
Date Published : 03/08/2017
NO 76 Baijia Road , Donguan City, CHINA
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/08/2017

Desc: Sunglasses

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 , Foshan City , Huang Qi, Nanhai, 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
Duqiao , Xiaqiao Road; Duqiaozhen 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
107 Country Road, West , Industry Development Area Shihling Town , Hua-Du City, 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

NEW ERA ENTERPRISE CO.,LTD.
Date Published : 10/13/2021
No.142-1 Zhengyi 3rd St., , Rende District , Tainan City, TAIWAN
86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 10/13/2021

Desc: Sunglasses


UNITED STATES


Glory International Trading Inc
Date Published : 03/02/2022
530 Ray St , Freeport, NY 11520-5238 UNITED STATES
86 H - - OI Spectacle, Magnifying
Date Published: 03/02/2022

Desc: Plastic Sunglasses
Notes: 6/27/2011

86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear)
Date Published: 03/02/2022

Desc: Plastic Sunglasses
Notes: 6/27/2011

86 H - - QY Sunglasses (Non-Prescription Including Photosensitive)
Date Published: 03/02/2022

Desc: Plastic Sunglasses
Notes: 6/27/2011