Import Alert 86-11

(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 # 86-11
Published Date: 10/16/2023
Type: DWPE

Import Alert Name:

"Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 09/01/2021 updates the guidance, agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***).

FDA has collected and analyzed samples of contact lenses (corrective and non-corrective (plano)) with potentially hazardous microbial contamination that may pose a health risk. Firms who have produced contact lenses with sterility and quality issues can create a potential health risk.

Guidance:

Divisions may detain, without physical examination, the specified products from the firms listed in the Red List of this Import Alert.

Divisions should recommend detention without physical examination under this import alert when analytical results reveal the presence of potentially hazardous microbial contamination. Forward background information, including analytical worksheets, product labeling and entry documents, to the Division of Import Operations (DIO). ***DIO will coordinate with the Center for Devices and Radiological Health (CDRH) for concurrence.***

***Release of Articles Subject to Detention without Physical Examination Under this Import Alert:

In order to secure the 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 evidence that the shipment does not contain contact lenses that have Microbiological Contamination. Such evidence could include private laboratory analysis of samples.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

***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 demonstrate that the firm has resolved the conditions that gave rise to the appearance of a violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the FD&C Act. For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, 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, be sent via email to: Importalerts2@fda.hhs.gov***

Requests for removal from detention without physical examination will be referred by DIO to CDRH for evaluation.

***Questions or issues involving import operations should be addressed to ORA/DIO at (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

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

Product Description:

Contact lenses. All approved or cleared contact lenses are prescription devices even if they have no power (plano) to correct vision. They are sometimes referenced by names such as cosmetic contact lenses, non-prescription contact lenses, vampire contacts, costume contact lenses, circle lenses, cosplay contact lenses, twilight contact lenses, Halloween contact lenses and novelty contact lenses. Decorative contact lenses change the look of your eyes but may also correct vision.

Charge:

***The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health. [Adulteration, Section 501(a)(2)(A)]

OASIS charge code: STERILITY

Or

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity and quality falls below, that which it purports or is represented to possess. [Adulteration, Section 501(c)]

OASIS charge code: DV QUALITY ***

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


HONG KONG SAR


Aspiration Intl
Date Published : 06/09/2015
Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG SAR
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/09/2015

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/09/2015

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/09/2015

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/09/2015

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/09/2015

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/09/2015

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/09/2015

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/09/2015

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/09/2015

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/09/2015

Desc: Contact Lenses


KOREA (THE REPUBLIC OF)


Con Tech Korea Co. Ltd.
Date Published : 06/16/2014
Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/16/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/16/2014

Desc: Contact Lenses

Contech Korea
Date Published : 06/16/2014
970-14 Wolchul-Dong , Gwangju, KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 06/16/2014

Desc: Contact Lenses

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - VN Lens, Contact (Disposable)
Date Published: 06/16/2014

Desc: Contact Lenses

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 06/16/2014

Desc: Contact Lenses

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 06/16/2014

Desc: Contact Lenses

GEO Medical Co., Ltd.
Date Published : 10/17/2013
Buk , 7 Cheomdanyeonsinro398beon-Gil , Buk, Gwangju KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

MAX LOOK CONTACT LENS / KIM
Date Published : 10/17/2013
105 HYEOPSEOK-RI , NAMCHEON-MYEON , GYEONGSAN-SI, GYEONGSANGBUGDO KOREA (THE REPUBLIC OF)
86 H - - PX Lens, Contact (Polymethylmethacrylate)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 H - - QD Lens, Contact (Other Material) - Daily
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 L - - PM Lenses, Soft Contact, Extended Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - UW Lens, Contact (Orthokeratology)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - VN Lens, Contact (Disposable)
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - CZ Lens, Contact, for Color Vision Deficiency
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - IC Lens, Contact, for Reading Discomfort
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II

86 N - - UU Lens, Contact, Orthokeratology, Overnight
Date Published: 10/17/2013

Desc: Contact Lenses
Notes: Class II


PHILIPPINES


C WORLD KSG CORPORATION
Date Published : 11/19/2015
NO 2 8th Street Golden Mile Business Par , Cavite, Calabarzon PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/19/2015

Desc: Contact lenses
Notes: All brands of contact lenses are subject to DWPE.                                                                                                               

RICHARD KIM
Date Published : 11/29/2016
The Levels Com , Cavite, Calabarzon PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/29/2016

Desc: Contact lenses
Notes: All brands of contact lenses are subject to DWPE.                                                                                                                                                                                                                                                                                                                                                                                                     

Richard Kim
Date Published : 11/29/2016
Unit 1206 , The Levels Anaheim Condo , Filinvest City, Muntinlupa City, PHILIPPINES
86 L - - PL Lenses, Soft Contact, Daily Wear
Date Published: 11/29/2016

Desc: Contact lenses
Notes: All brands of contact lenses are subject to DWPE.