# The One and Only Fashion Beauty Group, Inc. · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For The One and Only Fashion Beauty Group, Inc. · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product code is 86 H - - PK Tonograph | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort; date published is 09/16/2009; address is 74 Simcoe Road , Kettleby, Ontario, CANADA, verified against its source on 2026-09-16.

- **Firm:** The One and Only Fashion Beauty Group, Inc. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 74 Simcoe Road , Kettleby, Ontario, CANADA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 86 H - - PK Tonograph | 86 H - - QD Lens, Contact (Other Material) - Daily | 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - UW Lens, Contact (Orthokeratology) | 86 M - - VN Lens, Contact (Disposable) | 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear | 86 N - - CZ Lens, Contact, for Color Vision Deficiency | 86 N - - IC Lens, Contact, for Reading Discomfort _(verified: each item appears in the quote below)_
- **FDA notes:** Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. | Decorative Contact Lenses. 4/7/2006. _(verified: each item appears in the quote below)_

## What the source says

> The One and Only Fashion Beauty Group, Inc. Date Published : 09/16/2009 74 Simcoe Road , Kettleby, Ontario, CANADA 86 H - - PK Tonograph Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - VN Lens, Contact (Disposable) Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006. 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 09/16/2009 Notes: Decorative Contact Lenses. 4/7/2006.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).