In focus: Internet eye exams taken offline

Online refraction technology has been dealt a hammer blow after its main protagonist Visibly (formerly Opternative) was forced to withdraw services from digital platforms by the US Food and Drug Administration (FDA).

Opternative and subsequently Visibly’s online testing has been under FDA scrutiny for nearly three years, with the US regulator having alleged it had not granted authorisation to the company to market the test as a medical device. The process, known as 510k premarket approval, states that a device must be ‘at least as safe and effective,’ or ‘substantially equivalent’ to a legally marketed device that is not subject to FDA premarket approval.