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: 12/09/2020
Type: DWPE

Import Alert Name:

DETENTION WITHOUT PHYSICAL EXAMINATION OF CONTACT LENSES DUE

TO MICROBIOLOGICAL CONTAMINATION

Reason for Alert:

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:

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



Districts 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).



Requests for Removal from Detention Without Physical Examination Under This Import Alert:



Firms listed on the Red List of this import alert should provide documentation with sufficient evidence to demonstrate future shipments of their contact lens product(s) will not be adulterated.



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



All requests for removal from detention without physical examination may be sent via email to: Importalerts2@fda.hhs.gov



Or mailed to:



Food and Drug Administration

Division of Import Operations

12420 Parklawn Drive, ELEM-3109

Rockville, MD 20857



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



For questions or issues involving import operations, contact the Division of Import Operations, Import Operations and Maintenance Branch at (301) 796-0356.



For questions or issues concerning sample preparation or analytical methodology, contact the Office of Regulatory Science at oraorsprivatelabimportalerts@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 be adulterated since it consists in whole or in part of a filthy, putrid, or decomposed substance namely potentially infectious microorganisms. [Section 501(a)(1)]."



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 purity and quality fall below that which it is represented to possess [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


Aspiration Intl
Date Published : 06/09/2015
Unit 2706 , Mega Trade Centre; 1 Mei Wan St. , Tsuen Wan, New Territories HONG KONG
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, REPUBLIC OF (SOUTH)


Con Tech Korea Co. Ltd.
Date Published : 06/16/2014
Chunnan Techno College,Post Bi-A203 , Wolchul, KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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
20-10 Cheomdan venture so-ro 38 beon-gil , Gwangju, GWANGJU GWANGYEOGSI KOREA, REPUBLIC OF (SOUTH)
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, REPUBLIC OF (SOUTH)
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.