# Aqua Sole Company Ltd · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For Aqua Sole Company Ltd · 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 - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear); date published is 09/16/2009; address is 27 Passmore Ave Unit #1 , Scarborough, ON CANADA, verified against its source on 2026-09-16.

- **Firm:** Aqua Sole Company Ltd _(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:** 27 Passmore Ave Unit #1 , Scarborough, ON CANADA _(verified: appears in the quote below)_
- **Date published:** 09/16/2009 _(verified: appears in the quote below)_
- **Product code:** 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) _(verified: appears in the quote below)_
- **FDA notes:** Eye Mask or Eye Masque. _(verified: appears in the quote below)_

## What the source says

> Aqua Sole Company Ltd Date Published : 09/16/2009 27 Passmore Ave Unit #1 , Scarborough, ON CANADA 86 H - - OY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear and Post-Mydriatic Eyewear) Date Published: 09/16/2009 Notes: Eye Mask or Eye Masque.

## 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/).