SACRAMENTO, Calif.—The California Optometric Association
(COA) said on Wednesday that it is advising consumers in the state that online vision tests “come with significant safety concerns.” In addition, the COA said it has sent a letter to the California Attorney General in which it notes that the association believes “Opternative
, and its partner 1-800 Contacts
, appear to be violating an Oct. 30, 2017, Food and Drug Administration (FDA) letter demanding Opternative cease marketing its online product in violation of the Federal Food, Drug, and Cosmetic Act.”
Chicago-based Opternative, founded in 2012, launched the first online refractive eye test that delivers a physician-issued prescription for glasses or contact lenses and now offers the service in 39 states, according to its website.
In the letter to the California AG, COA president Ranjeet S. Bajwa, OD, FAAO, Dipl ABO, said the association believes public health is “potentially 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.” The letter added, “Therefore, the California Optometric Association respectfully requests your office take prompt action to protect the health and safety of 39.5 million residents by investigating the joint venture between Opternative and 1-800 Contacts.”
Asked about the COA announcement, an Opternative spokesman told VMAIL
, “This is nothing more than a PR stunt by the COA to stop innovation and emerging technologies. We are 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.”
Officials at 1-800 Contacts could not be reached for comment at VMAIL
’s press time.
Opternative previously noted in a statement that it responded promptly to the FDA's October 2017 warning letter and is “working diligently to voluntarily comply with all regulatory requirements,” as VMAIL reported
In January, Opternative and 1-800 Contacts renewed their partnership under which 1-800 Contacts will continue to use the Opternative online service to allows patients to update their prescriptions The renewed partnership came 18 months after the two companies signed their first partnership agreement, as VMAIL reported
In the COA announcement, Dr. Bajwa said, “California’s optometrists are warning patients about this unapproved technology because we are committed to protecting Californians’ vision and health. … Optometrists embrace the potential of telemedicine to bring patients closer to quality care, unfortunately this product does the opposite – closing crucial windows to detect diabetes and other underlying health conditions that affect vision and can take lives.”
In its October letter to Opternative, the FDA stated that the Opternative online eye test has not received the agency’s marketing clearance or approval. The letter also asked Opternative to file a premarket submission of information that would allow the agency to evaluate the test’s safety and effectiveness.