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U.S. Department of Health and Human Services

Class 2 Device Recall refractive vision test

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  Class 2 Device Recall refractive vision test see related information
Date Initiated by Firm May 20, 2019
Create Date August 08, 2019
Recall Status1 Open3, Classified
Recall Number Z-2223-2019
Recall Event ID 83298
Product Classification Medical device data system - Product Code OUG
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.
Code Information ALL
Recalling Firm/
Manufacturer		 Opternative Inc
1 N State St Ste 1500
Chicago IL 60602-3206
For Additional Information Contact Dr. Steven Lee
866-314-6941
Manufacturer Reason
for Recall		 Lack of 510K clearance
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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