Recall Z-2223-2019— Opternative Inc
Class II · Ongoing
Class II FDA medical device recall by Opternative Inc, initiated 2019-05-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Lack of 510K clearance.
- Recalling firm
- Opternative Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-05-20
- Firm location
- Chicago, IL, United States
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.
Reason for recall
Lack of 510K clearance
Data sourced from openFDA. This site is unofficial and independent of the FDA.