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Open, Classified

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.

FDA Recall Z-2223-2019 · Posted None

Recalling FirmOpternative Inc
Recall StatusOpen, Classified
Product CodeOUG
Date Initiated2019-05-20
Product Quantity32

Reason for Recall

Lack of 510K clearance

Firm Action

The Visibly Online Refractive Vision Test is being recalled since the firm has not received authorization from FDA to market the product.

Root Cause

No Marketing Application

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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