Z-2223-2019 Class II Ongoing
FDA device recall Z-2223-2019 was initiated by Opternative Inc on May 20, 2019 and is designated Class II. Reason for recall: Lack of 510K clearance The recall status is ongoing. Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- May 20, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
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
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.
Code Information
ALL