A Message From Dr. John Serri About EyeQue Working with the FDA

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EyeQue Team

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September 14, 2021

Since we launched EyeQue six years ago, our team of engineers, scientists, and eye doctors have developed innovative self-administered refractive error measurement devices using exclusive MIT-patented technology. More than 20 additional proprietary patents have been developed along the way. We have received numerous awards over the years from consumer organizations such as CES. Staying true to our mission, we remain dedicated to putting affordable, accurate, and convenient smartphone-based vision tests into the hands of millions of people. EyeQue saw demand for our at-home vision products triple during the year 2020, validating the interest in and need for smart phone-based vision tests.

All EyeQue products are registered with the FDA as Class I medical devices in a category that normally is afforded a 510(k) exemption; this class of products tend to be low risk and non-invasive. Despite being Class I, FDA thought our VisionCheck product should obtain a 510(k) clearance. After some preliminary correspondence and dialogue on the subject, to further comply if needed and to advance at-home medical device tests, we initiated a more formal conversation with the FDA in May 2021 through an Agency process in which FDA provided feedback on the need for a 510(k) clearance for VisionCheck. Because VisionCheck is so unique, in that it can be operated by laypersons (those who are not eye care professionals), and because the device employs new scientific principles not seen before in ophthalmic refractometers, on September 1, 2021, the FDA provided feedback that EyeQue should submit a 510(k) submission for review. Due to this feedback, EyeQue is working with FDA to file a 510(k) submission.

The FDA is allowing EyeQue’s continued distribution of VisionCheck while its 510(k) submission is under development and review. We look forward to continuing to work with the FDA and appreciate its promptness and guidance in providing feedback. By working with the FDA on VisionCheck, our newest product, the EyeQue VisionCheck 2, which operates on similar principles, will also undergo a 510(k) submission. This process will take time and therefore we do not foresee distribution in the U.S. market of VisionCheck 2 before mid-2022. We sincerely apologize for the delay and any inconveniences this may have caused. Separately, we have conducted and are currently engaged in several clinical trials. Our clinical studies support that our devices are safe and refraction measurements from our devices provide corrected visual acuity similar to those of standard in-office devices when used properly by adults.

Please don’t hesitate to reach out with questions or requests for more information. We will continue to provide updates. This is the future of vision care, and we are excited to bring it directly to our customers. We appreciate your patience and interest in EyeQue.

Sincerely,

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