Opternative Inc recalls its Visibly Online Refractive Vision Test software due to lack of 510K clearance. This software, part of the Visibly Vision Test Solution, requires regulatory approval before use.
Lack of 510K clearance
Opternative Inc has recalled its Visibly Online Refractive Vision Test software because it lacks required regulatory clearance (510K). This means the software may not meet safety standards before being used by customers.
The software lacks 510K clearance, which is a regulatory requirement for medical devices in the U.S. This means it may not have undergone necessary safety testing before being used. Without this clearance, the software could pose risks that are not yet known or addressed by regulators.
Users of the Visibly Vision Test Solution software who were given access by partners or customers. Those most at risk are individuals using the software for vision testing without proper regulatory approval.
The Visibly Online Refractive Vision Test software is part of the Visibly Vision Test Solution. It was provided to partners and customers for vision testing purposes.
Review if you have access to the Visibly Online Refractive Vision Test software through your partner or customer account.
The software lacks 510K clearance, which is a regulatory requirement for medical devices in the U.S. This means it may not have undergone necessary safety testing before being used.
The Visibly Online Refractive Vision Test software is part of the Visibly Vision Test Solution and was provided to partners and customers for vision testing.
The recall record does not specify a remedy, so there is no action required beyond checking if you have access to the software.
We’ve drafted a message you can send Optern: The Visibly to request your refund or repair — edit it as you like.
Subject: Recall Z-2223-2019 — Optern: The Visibly Optern: The Visibly Hello, I own a Optern: The Visibly that is covered by recall Z-2223-2019 from Optern: The Visibly. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
