Is SMILE Pro an Unstable Surgery with Limited Clinical Experience?

SMILE Pro, which officially launched in Korea in October 2023, has quickly attracted significant attention and is now actively performed at a select number of eye clinics. At Bright Eye Clinic, the surgery is being conducted successfully and reliably, leading to a rapid increase in SMILE Pro's market share.

This growth is partly due to the improved features of the SMILE Pro equipment, the VisuMax 800, but it can also be attributed to the technology and research data accumulated over time with SMILE LASIK and the VisuMax 500. While the introduction of the VisuMax 800 even though SMILE Pro has generated high expectations, there have also been concerns.

One of the main concerns is whether there are enough clinical (surgical) cases with this new equipment. This apprehension stems from past comparisons with third-generation vision correction equipment, where limited clinical experience raised questions about the ability to verify safety.

To address this, it can be stated that the VisuMax 800 has undergone sufficient clinical trials.

SMILE Pro: Extensively Clinically Tested Before Introduction in Korea

By the time SMILE Pro was introduced in Korea in October 2023, over 60,000 procedures had already been performed worldwide, establishing its safety. Since then, an additional 40,000 SMILE Pro surgeries have been conducted, meaning that the number of clinical cases specifically for SMILE Pro is also substantial.

One crucial point is that the same medical teams performed countless surgeries from SMILE LASIK to SMILE Pro. Since both procedures use the same surgical method, this consistency translates into a high level of proficiency among surgeons.

Currently, the VisuMax 500 is installed in 72 eye clinics nationwide, while the VisuMax 800, used for SMILE Pro, is installed in about 20. This means that only clinics meeting Zeiss's strict standards of expertise and technical skill can perform SMILE LASIK and SMILE Pro.

In total, these selected clinics and medical staff have handled over 1.1 million SMILE LASIK and SMILE Pro cases. At Bright Eye Clinic alone, over 110,000 SMILE LASIK surgeries have been performed since the installation of VisuMax in 2009. Most of the clinic's staff members have around 10 years of experience, enabling them to perform SMILE Pro with the highest level of confidence and skill.

As mentioned, SMILE Pro was introduced in Korea after rigorous validation through extensive international cases and approval by the U.S. and Korean Food and Drug Administrations. Given the added safety advantages from over a decade of expertise and continuous research with Zeiss, you can be assured that SMILE Pro is a stable procedure.

Thank you.