AOA presses for FDA enforcement focused on ‘Eyebot’ kiosk

Taking active steps to safeguard public health and patient safety, the AOA is calling for prompt Federal enforcement action, submitting a formal complaint to the U.S. Food and Drug Administration (FDA) focused on the Eyebot vision testing kiosk. 

Through a detailed legal complaint letter, dated March 24 and signed by AOA President Jacquie M. Bowen, O.D., the AOA specifies a series of federal compliance issues related to Eyebot’s regulatory classification, marketing claims, potential patient safety risks and lack of publicly available software validation. It calls for a full investigation and appropriate follow-up action by the FDA’s Center for Devices and Radiological Health. 

“The concerns outlined in this complaint are significant and, in the AOA’s view, warrant prompt investigation to protect the public from potential harm,” the letter states. “The rapid deployment of Eyebot kiosks across multiple states in high-traffic retail locations increases the urgency.” 

AOA outlines Eyebot concerns and requests action 

• Regulatory classification. The AOA asserts that the Eyebot system is comprised of three Class I medical devices—each designed to be used by or under the supervision of a trained eye care professional in a clinical setting. “However, Eyebot has combined all three devices into a single, self-administered consumer product deployed in retail environments without direct clinical supervision,” the letter states.
• Marketing claims. While Eyebot’s website states that the device is meant to be used by adults, its online content includes extensive discussion of children’s vision. “This content appears designed to imply that the Eyebot device is suitable for use with pediatric patients,” the letter states. 
• Patient safety. The AOA reports instances raising concerns about the accuracy and consistency of prescriptions generated by Eyebot, including instances of a single user receiving three different prescriptions and users reporting that Eyebot-generated prescriptions were significantly stronger than prescriptions provided through in-person examinations by licensed eye care professionals. “These accuracy concerns raise questions about the reliability and reproducibility of the device’s measurements,” the letter states. 
• Software validation. Eyebot is powered by proprietary software that integrates the outputs of three separate medical devices, processes the resulting data, and generates recommendations for eyeglass prescriptions, the letter states. But the AOA is not aware of any publicly available documentation indicating that Eyebot manufacturers have provided the FDA with validation of the software.

The letter concludes by requesting that the FDA take several actions, including evaluating whether Eyebot should be reclassified, investigating whether Eyebot’s manufacturers have provided documentation validating its software, and examining whether Eyebot’s marketing claims constitute misbranding. 

AOA and affiliates continue Eyebot scrutiny 

The letter is the latest in a series of actions by the AOA and its affiliates to protect patient safety by holding Eyebot accountable: 

November 2025: After assessing and testing Eyebot kiosks, the AOA alerted the Federal Trade Commission and the FDA of the need for further assessment to safeguard patient health and privacy, as well as raising potential regulatory concerns with the relationship between Eyebot and Zenni Optical. 

January 2026: The Pennsylvania Optometric Association (POA), an AOA affiliate, issued a formal patient safety alert regarding Eyebot kiosks piloted at 16 major retail locations in the state, asserting these 15-minute automated tests are no substitute for comprehensive eye care. 

February 2026: More than 1,600 optometry students nationwide, led by the American Optometric Student Association’s (AOSA’s) executive leadership, called for a commitment to patient health and safety.