Online sales of glasses and contact lenses, while unsavory to ODs, aren’t illegal. But the push by some start-ups to bring refraction and eye care into the digital realm is more tenuous. ODs have fought back with efforts aiming at preserving eye care into as an in-office experience for the sake of patient safety and satisfaction. Advocacy groups made headway earlier this month when Visibly, formerly known as Opternative, was forced to recall its online vision test on August 8; an FDA recall notice stated the test was violating federal law. The company failed to submit a marketing application and, therefore, did not have authorization to market the product.
The recall came after the FDA recognized the AOA’s concerns for more than three years regarding the health risks associated with the test, which the association argued did not comply with federal law. The AOA originally filed a formal complaint against Visibly in April 2016, emphasizing the company’s lack of premarket approval and calling for its removal from the market altogether. It wasn’t until 2017 that the FDA issued a warning letter to the online seller to immediately cease all activities that “result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device.”
"Optometrists and other physicians know that eye exams are essential care and that new health technologies must always enhance the doctor-patient relationship and help deliver improved outcomes," AOA President Barbara L. Horn, OD, said in an AOA statement. She added that it is equally important that they abide by the law.
The FDA notes that it will continue to monitor the company in light of the recent recall.
|AOA. FDA enforcement action disrupts vision test company. www.aoa.org/news/advocacy/fda-enforcement-action-disrupts-vision-test-company. August 22, 2019. Accessed on August 26, 2019.|