# EYEMERA Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For EYEMERA Co., Ltd. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Contact Lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear; date published is 12/26/2023; address is 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** EYEMERA Co., 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/26/2023 _(verified: appears in the quote below)_
- **Product code:** 86 L - - PL Lenses, Soft Contact, Daily Wear _(verified: appears in the quote below)_
- **Product:** Contact Lenses _(verified: appears in the quote below)_
- **FDA notes:** Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing. _(verified: appears in the quote below)_

## What the source says

> EYEMERA Co., Ltd. Date Published : 12/26/2023 146 Seongseo4chacheomdan-Ro , Dalseo, Daegu KOREA (THE REPUBLIC OF) 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 12/26/2023 Desc: Contact Lenses Notes: Contacts lenses packaged in plastic clamshell cases (blister packs) are subject to DWPE; glass vials are exempt from DWPE under this listing.

## 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/).