Chicago eye care startup Visibly has had its online vision testing tech recalled by the U.S. Food and Drug Administration.
The FDA issued a class 2 device recall for Visibly’s online refraction test because the startup hadn’t received authorization from the FDA to market the product, according to the Aug. 8 FDA notice.
On its website, the FDA says it issues a recall when a medical device violates FDA law, is defective or could be a risk to health. The FDA also states that a medical device recall does not always mean that it must stop being used or that it needs to be returned to the company. Sometimes, it simply means that the device needs to be checked, adjusted or fixed.
A Visibly representative did not respond to a request for comment as of press time.
Visibly, founded in 2012 by Steven Lee and formerly known as Opternative, has become known for its at-home, digital vision test that can be accessed through a smartphone or computer screen. Since the company’s inception, it has received criticism from the optometry community because Visibly’s tech appeared to be marketed as an alternative to a traditional eye exam.
The American Optometric Association even filed a formal complaint to the FDA about Visibly’s online tests in 2016, which resulted in the FDA issuing a warning letter to Visibly in 2017.
The next year, the startup changed its name to Visibly to better convey its B2B offerings to the optometry and eyewear industries.
Though Visibly’s test is designed for patients to take at home, the results are still reviewed remotely by third-party optometrists that work with Visibly, according to the company. Chicago Inno last reported that vision tests start at $35 and the company’s services are available in more than 30 states.
Additionally, glasses retailers work with Visibly as a way to more seamlessly sell eyewear to consumers whose prescriptions have been kickstarted by Visibly’s vision test. Visibly also offers eyewear companies the option to incorporate the startup’s vision test directly into their retail space.
As of December 2018, the company employed more than 50 people at its West Loop headquarters and has raised more than $18 million in venture capital funding.
