Opternative Inc recalls The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software applica…

Recall date

May 20, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2223-2019

FDA classification

Class II

Brand / firm

Opternative Inc

Sold / distributed

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.

Why it was recalled

Lack of 510K clearance

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.