Opternative Recalls Visibly Online Refractive Vision Test Software
Opternative Inc is recalling the Visibly Online Refractive Vision Test software because it lacks FDA 510(k) clearance. The software was distributed worldwide and in specific US states.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text cites a lack of 510(k) clearance as the sole reason without reporting any illnesses, injuries, or specific health hazards, fitting the criteria for a moderate severity voluntary or regulatory compliance recall.
Plain-English summary
Opternative Inc is recalling the Visibly Online Refractive Vision Test, a software application that is part of the Visibly Vision Test Solution. This online tool is used to measure vision refraction and was provided to partners and their customers. The recall is being conducted because the product lacks the required FDA 510(k) clearance.
The affected software was distributed worldwide, including in Canada and across the United States in the states of Arizona, California, Delaware, Florida, Illinois, Missouri, Nevada, New York, Ohio, Pennsylvania, Texas, Washington, and Utah. A total of 32 units are involved in this recall.
Consumers and partners who have access to this software should stop using it for vision testing. Users should contact Opternative Inc for further instructions regarding the recall and any necessary remediation.
The recalled product
- 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…
- Manufacturer
- Opternative Inc
- Category
- Medical Device — Software
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL
Distribution
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