The Visibly Online Refractive Vision Test which is part of the… — Class II medical device recall Z-2223-2019
Ongoing recall by Opternative Inc, reported 2019-08-14, distributed nationwide. Lack of 510K clearance
| Recall number | Z-2223-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Opternative Inc, Chicago, IL, United States |
| Recall initiated | 2019-05-20 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 32 |
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 for recall
Lack of 510K clearance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2223-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.