Recall Z-2223-2019 ยท OUG Medical Device Data System
Opternative Inc
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.
| Date | May 20, 2019 |
| Status | Open, Classified |
| Reason | Lack of 510K clearance |
| Root cause | No Marketing Application |
| Action | The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product. |
| Quantity | 32 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.