Opternative is back in the hot seat today as the California Optometric Association (COA) recently complained to the state’s attorney general about the online refraction company’s practices. The COA asked Attorney General Xavier Becerra to “take prompt action […] by investigating” the joint venture between Opternative and 1-800 Contacts, asserting that the company is violating the Federal Food, Drug, and Cosmetic Act.1
In the letter, COA President Ranjeet S. Bajwa, OD, repeats an oft-heard refrain in optometric circles saying that public health is “threatened by a medical device actively marketed to the public, despite not having gone through the required review and approval processes demanded by the FDA.”1
The COA letter is referring to another letter sent by the FDA in October 2017 to Opternative, indicating that the company has been operating in violation of the Federal Food, Drug, and Cosmetic Act.2 The FDA requested “that Opternative, Inc. immediately cease activities that result in the misbranding or adulteration of the On-Line Opternative Eye Examination Mobile Medical App device, such as the commercial distribution of the device through your online website.” Opternative told Review of Optometry in April 2018 that it “responded promptly to FDA’s warning letter from October 2017 and we are working diligently to voluntarily comply with all regulatory requirements.”
“This is nothing more than a PR stunt by the COA,” says Peter Horkan, Opternative’s vice president of government and external relations. He adds that the company is “grateful to our OD/ECP partners in California who have embraced increased access to vision screenings, and we look forward to growing our partnerships in that state.”
That partnership may include a new software platform the company launched recently, EZRx. That technology enables an eye care practice to include digital refractions and visual acuity tests on its own website, potentially bringing optometrists into the mix by associating the software with individual practices. In turn, practice owners are charged a subscription fee.3
The California organization is going one step further by collecting what it calls “evidence” from ODs of “patients who met the qualifications for an exam on the Opternative website, but who went to an optometrist instead and were diagnosed with a serious eye condition that would not have been detected by the Opternative website.” Their aim is to “demonstrate to regulators that online eye tests, like Opternative, are potentially harmful to patients.”1
1. California Optometric Association. California optometrists caution patients about unapproved, online ‘vision tests’ after FDA warning. COAVision. www.coavision.org/files/05%2009%2018%20Opternative%20Release%20FINAL.pdf. Accessed May 10, 2018.