Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 14, 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 the Visibly Vision Test Solution is used to measure vision refraction.
Lack of 510K clearance
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Opternative Inc recalled The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Soluti… - a moderate-severity action.
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Soluti… was recalled by Opternative Inc in August 14, 2019. Reason: Lack of 510K clearance. Check the official notice for the remedy. Verify recall #Z-2223-2019 with the FDA Devices before acting.
The recall
Opternative Inc issued this moderate-severity FDA Devices recall-Lack of 510K clearance.
- Moderate
- severity level
- 32 units
- affected scope
- Class II
- classification
- August 14, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2223-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2223-2019) was formally reported on August 14, 2019, with the manufacturer initiating the action on May 20, 2019. It is classified under Moderate severity (Class II), with a current status of Ongoing. Opternative Inc is listed as the recalling firm, operating out of Chicago, IL. Federal records list the affected scope as 32.
The documented reason for this recall is: Lack of 510K clearance Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Where this recall sits in the database
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
32
Related Recalls
6
0 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2223-2019 |
| Date reported | August 14, 2019 |
| Date initiated | May 20, 2019 |
| Recalling firm | Opternative Inc |
| Firm location | Chicago, IL |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2223-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Opternative Inc. Units affected: 32.
Why was this product recalled? ▼
Lack of 510K clearance
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2223-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2223-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 14, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.