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.
- Company
- Opternative Inc
- Recall Initiated
- May 20, 2019
- Recall Number
- Z-2223-2019
- Quantity
- 32
- Firm Location
- Chicago, IL
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.
Lot / Code Info
ALL
Root Cause
No Marketing Application
Action Taken
The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.