In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.
This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years. In October of 2017, the FDA sent the company a letter that mades it clear that it considered Opternative's online eye exam to be a mobile medical app that requires premarket clearance. The company had registered the product as a Class 1 device.
After the warning letter was written, Visibly told MobiHealthNews that it was “working closely with the FDA on this matter.”
Visibly has been careful to emphasize that it provides only a refraction eye exam, not the comprehensive exams a user would receive at an eye doctor.
“Visibly is not a replacement for a comprehensive eye health examination,” the company writes at the bottom of its webpage. “We recommend patients go to the eye doctor for a comprehensive eye exam every two years. Our licensed ophthalmologists and optometrists use Visibly's online technology to evaluate a patient's visual acuity and a portion of the ocular health profile and issue a prescription for corrective eyewear, where clinically appropriate.”
MobiHealthNews has reached out to Visibly for a statement and will update the article accordingly.
WHY IT MATTERS
Online vision tests have been a contentious topic in the optometry field. This recall could mean there are more hurdles yet ahead. The American Optometry Association has raised concerns about the technology in the past.
“Currently marketed online vision screenings claim to test a person’s visual acuity, but this is just one of the 12 essential components of a comprehensive eye exam,” the AOA wrote in an email statement to MobiHealthNews. “An in-person eye exam with an eye doctor is the medically-recognized standard to assure healthy vision, identify and treat diseases such as dry eye and glaucoma, as well as ensure early diagnosis of immediate threats to overall health, including hypertension, stroke and diabetes, which may have no obvious signs.”
THE LARGER TREND
Visibly has faced a number of legal obstacles in recent years. In April, the startup filed a complaint in Indiana seeking to overturn a law prohibiting providers from prescribing corrective lenses via telemedicine in the state. Additionally, last January a South Carolina judge dismissed the company’s case against the South Carolina Board of Medical Examiners and Department of Labor, Licensing and Regulations, which alleged that a newly passed law restricting online eye exams was protectionist, unconstitutional legislation.