Opternative Inc: Medical Device Recall in 2019 - (Recall #: Z-2223-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 20, 2019

Date Posted: August 14, 2019

Recall Number: Z-2223-2019

Event ID: 83298

Reason for Recall:

Lack of 510K clearance

Status: Ongoing

Product Quantity: 32

Code Information:

ALL

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated