# Sclera Contact Lenses · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For Sclera Contact Lenses · 89-08 · UNITED KINGDOM, 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 UNITED KINGDOM; product is Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses; product code is 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 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 11/07/2014; address is 56 Games Road The Gatewaycockfosters , Cockfosterscockfosters, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** Sclera Contact Lenses _(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:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** 56 Games Road The Gatewaycockfosters , Cockfosterscockfosters, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 11/07/2014 _(verified: appears in the quote below)_
- **Product code:** 86 H - - PX Lens, Contact (Polymethylmethacrylate) | 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)_
- **Product:** Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses | Contact Lenses _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II | Class II _(verified: each item appears in the quote below)_

## What the source says

> Sclera Contact Lenses Date Published : 11/07/2014 56 Games Road The Gatewaycockfosters , Cockfosterscockfosters, UNITED KINGDOM 86 H - - PX Lens, Contact (Polymethylmethacrylate) Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 H - - QD Lens, Contact (Other Material) - Daily Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 M - - UW Lens, Contact (Orthokeratology) Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 M - - VN Lens, Contact (Disposable) Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 M - - WL Lens, Contact (Rigid Gas Permeable) - Extended Wear Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 N - - CZ Lens, Contact, for Color Vision Deficiency Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II 86 N - - IC Lens, Contact, for Reading Discomfort Date Published: 11/07/2014 Desc: Contact Lenses Notes: Class II

## 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/).