AOA presses for FDA enforcement focused on ‘Eyebot’ kiosk

March 25, 2026

Detailed legal complaint documents patient safety, health and product claim concerns—and seeks immediate federal agency enforcement action.

Key Takeaways

The AOA asserts that Eyebot combines three Class I medical devices—each intended for use by or under the supervision of a trained eye care professional—into a single, self-administered product deployed in retail settings without clinical oversight.
While Eyebot’s website states the device is intended for adults, its marketing includes extensive references to children’s vision, potentially implying pediatric use.
The AOA has received reports raising concerns about inconsistent and potentially inaccurate prescriptions generated by Eyebot.

The AOA is not aware of any publicly available documentation showing that Eyebot manufacturers have provided the FDA with software validation.
The letter represents the latest step in AOA’s ongoing efforts to hold Eyebot accountable and safeguard patient care.