FDA Cracks Down on Online Vision Screening Service


The FDA recently released a warning for a company whose business is focused on creating online prescriptions for patients doing a home vision test. But the concern is that this is a medical device, which never got clearance.

What can't you do online these days? Dating, eating, finding rides, shopping, refilling your medications; there are services for everything it seems. So why not do your vision screening online as well? Makes sense right?! I mean, you just need to say which image looks better. But wait, don't you need to schedule an appointment, and have this testing done by an optometrist? What about all of the lens testing they do to make sure your vision is correct?

Well, there's the rub. You see, there are several companies marketing online vision screening tools, but 1 is on the FDA's bad side. Opternative, is an online vision screening company, and it's worth discussing how they work before we jump into the FDA warning, released in March.1,2

The process is relatively simple. All you need is a computer, a smartphone, and 10 feet of space, along with your old prescription. So, the website will walk you through the process, by telling how to layout everything (where to stand, where to put the computer, etc.). Then they will measure your vision. I really am not sure how this works, I tried looking up videos of it in action or see if they released any papers on the process, and the only thing I can come up with is that it seems to replicate the actual process of an in-person appointment, by displaying letters and symbols that you determine you can see with your smartphone serving as the medium for response. It's kinda cool, being able to do this in your home, and I could see the value for those that don't want to schedule an appointment and leave their home, especially considering the fact you get an actual prescription (reviewed by an optometrist) at the end of the session, and all for between $50-60.

Now Opternative isn't for everyone. You can't do any other screenings for the eye, so that negates any health aspects of the platform aside from just getting a new prescription. It can only be used for those between 18-55 years of age and in relatively good health. My guess is they want to negate the risk of patients with any eye issues stemming from any comorbidities (e.g., retinopathy secondary to diabetes) or those with glaucoma. Lastly, it's only available in 37 states, due to rules and regulations surrounding these types of telemedicine/virtual diagnostic services.

So why did the FDA file a warning letter to Opternative in October, which was made public last month?2 Well, it is because the FDA feels that the Optternative platform falls under its jurisdiction as a health device. Or more specifically, "Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body." And, apparently Opternative did not have FDA clearance or approval to market the product, which is a big problem.

This isn't relatively new. The American Optometric Association has been lambasting these types of companies for the past 2 years, and released a complaint to the FDA back in April 2016.3 Steven Loomis, O.D. at the time pointed out that association officials "...are very worried that personalized, in-person, high-quality health care is increasingly under attack " by corporations promoting unproven products, and shortcuts that lower the bar on quality care standards, and put patients at risk."" The essential concern, though, was that did these at-home self-screenings actually produce good results that were clinically correct? That being the case, the AOA was happy to see their concerns vindicated with the FDA warning, and hope to continue their advocacy for their patients.4

So, why do I care about this, especially in regards to pharmacists? I really think there are some similarities to the widespread use by patients for information on the internet that are replacing our services. Pharmacists have for decades championed themselves as the drug information experts for the community, and I genuinely believe that was the case when patients had no access to medical literature, in the past. But now, so many companies are based on the concept of getting patients drug information, pill ID, and disease information, that it negates any such service.

Pharmacists have also been seeking to achieve midlevel practitioner status, but other companies are providing similar services through telemedicine services. In many ways, optometrists, pharmacists, and others are facing the tumult of trying to find out what we provide to our patients when the internet can supplant such traditional roles, and leaves me wondering if this will even out in the next few years or worsen (depending on what side of the fence you sit on regarding the role of technology in patient care). I suspect to see further marketing and advocacy similar to how the AOA targeted Opternative, with pharmacy also doing similar outreaches with concerns about patients not using pharmacists as drug resources, and the need for patients to 'talk to their pharmacists' before turning online for information.


  • Opternative. https://www.opternative.com/. Accessed April 9, 2018.
  • Opternative Inc 10/30/17. FDA Warning Letter. https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm600029.htm. Accessed April 9, 2018.
  • AOA files expansive FDA complaint against Opternative. April 4, 2016. http://www.aoa.org/news/advocacy/aoa-files-expansive-fda-complaint-against-opternative?sso=y. Accessed April 9, 2018.
  • FDA: Opternative in violation of federal law; AOA complaint validated. March 15, 2018. http://www.aoa.org/news/advocacy/fda-warning-to-opternative-march-18. Accessed April 9, 2018.

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