Device Safety

1. Laser safety

The Eyerising Myopia Management Device underwent IEC 60825:1-2014 testing, the laser product safety standard required for CE marking, at Seibersdorf Labor GmBH, a laser safety test house in Austria. This test uses a 7mm aperture mimicking the pupil as required by the standard as a worst-case scenario, and classifies lasers from Class 1 (safe in all cases) to Class 4 (hazardous).

The Eyerising Myopia Management Device was found to have emissions typically slightly below 1mW, which would classify as Class 2. However, there was one emission of 1.03mW which would exceed the 1mW limit and classify as Class 3R. Therefore, the device was classified as Class 3R.

A subsequent expert opinion of Dr Karl Schulmeister from Seibersdorf Labor GmBH reviewed the results of the IEC 60825:1-2014 and the protocol of the Eyerising Myopia Management Device to explain its safety profile with regard to repeated retinal exposure, particularly as a novel product class of a low-power laser intended for repeated therapy, as opposed to the high-power lasers typically used in ophthalmology. The report concluded that based off of known injury thresholds and previous human experiments, as well as the likely constriction of the pupil when viewing the Eyerising Myopia Management Device, there is negligible risk of retinal injury when using the device, including for repeated exposures.

For more information or a full copy of this report, please contact info@eyerisinginternational.com.

2. Clinical Evidence

Our device has undergone extensive clinical study, with over 15 clinical trials and 4 real-world studies published in China. Collectively over these parallel studies, which have ranged in duration from 1 month to 2 years, over 2000 patients have been involved. We also have 5 ongoing clinical trials and real-world studies outside of China, with promising interim results from our Australian trial on multi-ethnic efficacy, Japanese trial on high myopia, and Spain trial on adjunct use with orthokeratology. Importantly, in all our published studies thus far across a variety of institutions, no serious adverse events have been reported.

Our key clinical evidence is available on our Science Hub. As new literature is constantly being published on repeated low-level red-light therapy, we also offer updates regarding new pertinent articles on our News page. For any other enquiries on our clinical evidence, ongoing and future research, please contact info@eyerisinginternational.com.

3. Long-term Device Use

The Eyerising device has been in the market for over 8 years and is the originator and patent holder of RLRL therapy for myopia management. This comprises 4 years of off-label and over 4 years of on-label use, thereby providing ample data on its safety profile over several years of real-world usage.

4. Post-market Surveillance

We also have global monitoring in place for our current users, in order to continually confirm our device’s safety. To date, the device is used by over 80,000+ current users globally. In this time, there have been 5 significant adverse events reported during post-market surveillance, all of which demonstrated complete recovery on treatment discontinuation.

Adverse events are difficult to avoid when launching novel medical devices, and our limited number of adverse events reported (<0.001%) within our wealth of real-world experience speaks to the safety profile of our intervention, as well as our commitment to fully updating our risk profile and ‘Instructions For Use’ accordingly as we gather more information.

5. Regulatory Approvals

The device meets the quality, safety, and efficacy standards required by medical regulators in over 30 countries across Europe and Australasia, with many more coming soon.

• Europe: CE mark, Class IIa
• UK: MHRA, Class IIa
• New Zealand: MedSafe, Class IIa
• Turkey: TMMDA, Class IIa
• Australia: Australian Register of Therapeutic Goods (ARTG), Class IIa
• Malaysia: Medical Device Authority (MDA), Class B
• Vietnam: Ministry of Health, Class B

As a company, Eyerising International is also ISO 13485:2016 certified. For more information on our availability in your country, please contact info@eyerisinginternational.com.

In summary:

• An expert opinion from an independent laser safety test house has concluded negligible risk of retinal injury when using the Eyerising Myopia Management Device
• We have undergone and are continuing to undergo extensive clinical studies, with no significant adverse events reported in our published work
• Through the device’s 8 years and 80,000+ patients to date, only 5 significant adverse events have been reported and all patients made a full recovery
• We are available in over 34 countries following risk-benefit analyses by the appropriate medical device regulators