FDA recall Z-2223-2019

Opternative Inc · Class II · device

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

Status
Ongoing
Initiation date
2019-05-20
Report date
2019-08-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Chicago, IL, United States

Primary source

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