Yes. ZEISS VISUMAX 800 with SMILE Pro software received approval from the U.S. Food and Drug Administration (FDA) in January 2024 for the correction of myopia (nearsightedness), with or without astigmatism.
SMILE Pro is the latest generation of lenticule extraction technology developed by ZEISS, performed using the VISUMAX 800 femtosecond laser system. But what does FDA approved actually mean, and how does SMILE Pro differ from other laser vision correction procedures?
Is SMILE Pro Really FDA Approved?
Yes.
In January 2024, the U.S. FDA approved ZEISS VISUMAX 800 with SMILE Pro software for the treatment of myopia, with or without astigmatism. VISUMAX 800 is ZEISS’s newest femtosecond laser platform for laser vision correction. FDA approval for a medical device means that the device has undergone regulatory review and has been authorized for specific indications based on available evidence. Therefore, the term “FDA approved” should always be used accurately and only for the indications that have received FDA authorization.
What Is SMILE Pro?
SMILE Pro is a laser vision correction procedure that uses the Small Incision Lenticule Extraction (SMILE) technique. During the procedure, a femtosecond laser creates a thin, lens-shaped piece of tissue (called a lenticule) within the cornea. The ophthalmologist then removes the lenticule through a small incision. Removing this tissue reshapes the cornea, helping correct refractive errors based on the patient’s prescription. Unlike LASIK, which requires creating a corneal flap, SMILE Pro uses a minimally invasive small-incision approach without creating a flap.
ZEISS VISUMAX 800 Technology Behind SMILE Pro
SMILE Pro is performed using the ZEISS VISUMAX 800 femtosecond laser platform. According to ZEISS, the system operates at a 2 MHz laser repetition rate and can create the corneal lenticule in less than 10 seconds.
VISUMAX 800 also incorporates several advanced technologies, including:
- CentraLign® to assist with centration
- OcuLign® to help compensate for cyclotorsion
- A digital workflow designed to streamline the treatment process
These technologies are intended to support surgical precision and improve workflow efficiency during laser vision correction procedures.
What Does FDA Approval Mean for SMILE Pro?
The U.S. Food and Drug Administration (FDA) is the regulatory agency responsible for evaluating and overseeing medical devices in the United States. FDA approval does not mean that a procedure is suitable for everyone or completely free of risks. Instead, it indicates that the medical device has been evaluated and authorized for specific intended uses.
For ZEISS VISUMAX 800 with SMILE Pro software, FDA approval covers the correction of myopia, with or without astigmatism, within the approved indications. Every patient must still undergo a comprehensive eye examination to determine whether they are an appropriate candidate for the procedure.
How Is SMILE Pro Different From Earlier SMILE Technology?
Both SMILE and SMILE Pro are based on the same lenticule extraction principle. The primary differences lie in the laser platform and supporting technologies. VISUMAX 800 offers a higher laser repetition rate than previous generations, allowing the lenticule to be created more quickly.
According to ZEISS, lenticule creation takes less than 10 seconds. However, this does not represent the total procedure time. Patients still undergo preparation, positioning, laser treatment, and lenticule removal by the surgeon.
Is SMILE Pro the Same as LASIK?
No.
Both LASIK and SMILE Pro are laser vision correction procedures, but they use different surgical techniques. In LASIK, the surgeon creates a corneal flap before reshaping the cornea with a laser. In SMILE Pro, the lenticule is created inside the cornea and removed through a small incision without creating a corneal flap.
Choosing the most appropriate procedure is not simply a matter of selecting the newest technology. Corneal anatomy, refractive error, overall eye health, and the results of a preoperative evaluation all play important roles in determining the best treatment option.
Who Is a Candidate for SMILE Pro?
Not everyone with myopia is automatically eligible for SMILE Pro. Suitability must be determined through a comprehensive eye examination. Your ophthalmologist will evaluate factors such as:
- Degree of myopia and astigmatism
- Stability of your refractive error
- Corneal thickness and shape
- Ocular surface health
- Overall eye health
- Previous eye diseases or surgeries
Approved indications may also vary according to local regulations in different countries. Therefore, a pre-SMILE Pro evaluation is an essential step before treatment.
Is SMILE Pro Safe?
SMILE Pro is an advanced laser vision correction technology that has received FDA approval for specific indications in the United States. However, like all medical procedures, SMILE Pro carries potential risks and side effects. Some patients may temporarily experience dry eyes, glare, halos, or changes in visual quality after surgery.
Individual outcomes vary, and careful patient selection combined with a thorough preoperative evaluation plays a critical role in achieving the best possible results.
Does FDA Approval Mean SMILE Pro Is Right for Me?
No.
FDA approval applies to the medical device and its approved indications—not to every individual patient. Even two people with the same eyeglass prescription may have different corneal characteristics or overall eye health. Whether SMILE Pro is appropriate for you can only be determined after a comprehensive eye examination and consultation with an ophthalmologist.
Don’t Choose Vision Correction Based on Trends Alone
Laser vision correction technology continues to evolve. SMILE Pro with ZEISS VISUMAX 800 represents one of the latest advancements in lenticule extraction and has received FDA approval in the United States for correcting myopia, with or without astigmatism. However, the best vision correction procedure is the one that is most appropriate for your individual eyes—not necessarily the newest technology available.
Interested in finding out whether you’re a candidate for SMILE Pro? Schedule a pre-SMILE Pro evaluation with an ophthalmologist to determine the most suitable vision correction option for your eyes.
FAQs About SMILE Pro and the FDA
Yes. ZEISS VISUMAX 800 with SMILE Pro software received U.S. FDA approval in January 2024 for the correction of myopia, with or without astigmatism, within its approved indications.
No. LASIK involves creating a corneal flap, while SMILE Pro corrects vision by removing a corneal lenticule through a small incision without creating a flap.
According to ZEISS, the VISUMAX 800 can create the corneal lenticule in less than 10 seconds. This refers only to the laser portion of the procedure, not the total treatment time.
No. Eligibility depends on several factors, including refractive error, corneal thickness, ocular surface health, and overall eye health, all of which are assessed during a preoperative examination.
No. Like any medical procedure, SMILE Pro carries potential risks and side effects. A thorough eye examination and consultation with an ophthalmologist are essential before deciding whether the procedure is appropriate.
Referensi:
U.S. Food and Drug Administration. Premarket Approval: VisuMax Femtosecond Laser.
ZEISS Medical Technology. U.S. FDA Approves the VISUMAX 800 with SMILE Pro Software. 2024.
American Academy of Ophthalmology. SMILE Eye Surgery.
Reinstein DZ, et al. Small Incision Lenticule Extraction: A Review of the First Decade. Journal of Refractive Surgery.
Moshirfar M, et al. Small Incision Lenticule Extraction: Surgical Technique and Outcomes.
