Device recall

Z-2223-2019: The Visibly Online Refractive Vision Test which is part of the Visibly Vision…

FDA device recall · Class II · Opternative Inc

Key facts

Recall number (Z-number) Z-2223-2019
Recall event 83298
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
Recalling firm Opternative Inc
Recall class Class II
Status Open, Classified
FEI number 3011276494

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)