Chicago, IL, United States
Opternative Inc recalls
1 recall recorded since 2018, most recently on 20 May 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2019
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2223-2019
- 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 th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.