FDA Medical Device Recalls (openFDA)
Opternative Inc: 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.
- Recall number
- Z-2223-2019
- 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.
- Status
- Open, Classified
- Initiated
- 2019-05-20
- Posted
- not on file
- Terminated
- not on file
- Reason
- Lack of 510K clearance
- 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
- 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.
- Lot, serial or model codes
- ALL
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OUG
- Firm FEI
- 3011276494
- Firm city
- Chicago
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28