# VISION SCIENCE CO · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For VISION SCIENCE CO · 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 Dimplecolor colour lenses | Dimplecolor colour lenses | Dimplecolor colour lenses; product code is 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - VN Lens, Contact (Disposable); date published is 01/20/2026; address is 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** VISION SCIENCE CO _(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:** 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 01/20/2026 _(verified: appears in the quote below)_
- **Product code:** 86 L - - PL Lenses, Soft Contact, Daily Wear | 86 L - - PM Lenses, Soft Contact, Extended Wear | 86 M - - VN Lens, Contact (Disposable) _(verified: each item appears in the quote below)_
- **Product:** Dimplecolor colour lenses | Dimplecolor colour lenses | Dimplecolor colour lenses _(verified: each item appears in the quote below)_
- **FDA notes:** labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). | labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). | labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). _(verified: each item appears in the quote below)_

## What the source says

> VISION SCIENCE CO Date Published : 01/20/2026 7 Jainro7-Gil , Jain-Myeon , Gyeongsan, Gyeongsangbuk KOREA (THE REPUBLIC OF) 86 L - - PL Lenses, Soft Contact, Daily Wear Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). 86 L - - PM Lenses, Soft Contact, Extended Wear Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months). 86 M - - VN Lens, Contact (Disposable) Date Published: 01/20/2026 Desc: Dimplecolor colour lenses Notes: labeling is not cleared to include a recommended replacement schedule (e.g., 3 months).

## 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/).