Z-2223-2019Class II

The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a...

Name: Z-2223-2019 The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a...
Creator: Opternative Inc
Published: 2019-05-20
License: https://open.fda.gov/license/

Opternative Inc / initiated 2019-05-20 / Open, Classified

FDA source

Opternative Inc began a recall of 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... on 2019-05-20. FDA classified it as Class II and gives the reason as "Lack of 510K clearance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2223-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-20
Posted: 2019-08-08
Recalling firm: Opternative Inc
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.
Product code: OUG Medical Device Data System
Reason for recall: Lack of 510K clearance
FDA root cause: No Marketing Application
Action: The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.
Quantity in commerce: 32
Distribution: Worldwide distribution. US Nationwide distribution in the states of AZ, CA, DE, FL, IL, MO, NV, NY, OH, PA, TX, WA, and UT. Country of Canada.
Product codes and lots: ALL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2223-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2223-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-08-14	2019-08-08

Product code OUG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)