FDA Device recall Z-2223-2019
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners a…
- FDA Device
- Class II
- ongoing
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners a… by Opternative, citing lack of 510K clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2223-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-20 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Opternative |
| Distribution | US |
Product
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.
Reason
Lack of 510K clearance
Identifiers
| code_info | ALL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2223-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.