Class 2 Device Recall refractive vision test

• Date Initiated by Firm: May 20, 2019
• Create Date: August 08, 2019
• Recall Status: Open, 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: 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.