# Institute for Vision Improvement · 89-08 · SOUTH AFRICA — FDA import alert red lists: firms subject to detention without physical examination

For Institute for Vision Improvement · 89-08 · SOUTH AFRICA, 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 SOUTH AFRICA; product is Lens; Spectacle; Non-Custom (Prescription) | Frame; Spectacle; product code is 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle; date published is 08/15/2022; address is PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA, verified against its source on 2026-09-16.

- **Firm:** Institute for Vision Improvement _(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:** SOUTH AFRICA _(verified: appears in the quote below)_
- **Address:** PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA _(verified: appears in the quote below)_
- **Date published:** 08/15/2022 _(verified: appears in the quote below)_
- **Product code:** 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) | 86 H - - QZ Frame, Spectacle _(verified: each item appears in the quote below)_
- **Product:** Lens; Spectacle; Non-Custom (Prescription) | Frame; Spectacle _(verified: each item appears in the quote below)_
- **FDA notes:** No 510K | No 510K _(verified: each item appears in the quote below)_

## What the source says

> Institute for Vision Improvement Date Published : 08/15/2022 PO Box 7840 , Johannesburg, Gauteng SOUTH AFRICA 86 H - - QG Lens, Spectacle, Non-Custom (Prescription) Date Published: 08/15/2022 Desc: Lens; Spectacle; Non-Custom (Prescription) Notes: No 510K 86 H - - QZ Frame, Spectacle Date Published: 08/15/2022 Desc: Frame; Spectacle Notes: No 510K

## 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/).