# FDA recall Z-2223-2019

> **Opternative Inc** · Class II · device recall initiated 2019-05-20.

## 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

## 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.

## Key facts

- **Recall number:** Z-2223-2019
- **Recalling firm:** Opternative Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-20
- **Report date:** 2019-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Chicago, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2223-2019

## Citation

> AI Analytics. FDA recall Z-2223-2019. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-2223-2019. Source: US FDA. Licensed CC0.

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