Laser cut
The femtosecond laser outlines a lenticule within the stroma and a small access incision.
Surgical Co-Management · Refractive
SMILE Lenticule Extraction flapless femtosecond refractive surgery.
In small incision lenticule extraction, a femtosecond laser cuts a thin lens-shaped piece of stroma inside the cornea, and the surgeon removes it through a small incision. There is no excimer ablation and no hinged flap. ZEISS performs it on its VISUMAX femtosecond laser.
Jan 2024FDA approval of VISUMAX 800 with SMILE pro
<10 sLenticule creation time ZEISS reports
2 MHzLaser pulse repetition rate
8M+Eyes treated with SMILE worldwide, per ZEISS
Quick answer
Same goal as LASIK, different route.
SMILE treats nearsightedness with or without astigmatism by removing tissue from inside the cornea. For the referring practice, screening looks much like LASIK screening: stable refraction, healthy corneal shape and a treated ocular surface. Post-op care centers on the incision, the interface and dryness.
Key takeaways
- FDA approval for VISUMAX 800 with SMILE pro covers myopia with or without astigmatism.
- The lenticule is cut by femtosecond laser, then extracted.
- No excimer laser and no hinged flap.
- Screen the same way you screen LASIK candidates.
- Check the surgeon's current indications before referring hyperopes.
How it works
Three steps inside the cornea.
The sequence below summarizes how the procedure is described by its manufacturer.
Extraction
The surgeon separates the lenticule and removes it through the incision.
Reshaped cornea
Removing the lenticule changes the corneal curvature and the refraction.
Practice pearl
Ask referral surgeons which procedures they offer and why they would steer a patient toward SMILE, LASIK or PRK. Repeating their reasoning accurately keeps your counseling consistent with theirs.
RescueLink
Dry eye before and after laser vision correction.
LASIK tends to aggravate dry eye, and severe cases can persist. When the surgeon clears it, send patients an eligible over-the-counter list of preservative-free drops, lid care and night protection through RescueLink. Your practice earns a 15% participation credit on eligible OTC orders on VisionRescue.com.
- No setup fee, subscription or quota
- One-tap ordering for the patient
- Optional auto-ship on recurring items
- Contact lenses and prescription products are excluded
Frequently asked questions
Is SMILE FDA approved?
Yes. ZEISS announced FDA approval of the VISUMAX 800 with SMILE pro software on January 11, 2024, for nearsightedness with or without astigmatism.
Does SMILE treat farsightedness?
The 2024 U.S. approval covers myopia with or without astigmatism. Check current labeling for any other indications.
How fast is the laser step?
ZEISS reports lenticule creation in under 10 seconds with a 2 MHz pulse rate, based on data on file.
What do I look for post-op?
Incision healing, interface clarity, inflammation and dry eye, plus refraction once stable.
References
- ZEISS. U.S. FDA approves the VISUMAX 800 with SMILE pro software, January 11, 2024. ZEISS
- FDA. When is LASIK not for me? FDA
- Every source behind this guide is listed on the Vision Rescue sources page. All sources
About this guide
Written for licensed eye care practices by the Vision Rescue team from manufacturer, FDA, CMS and peer-reviewed sources. Questions: providers@visionrescue.com or 1-855-692-8024.
Important notes and disclosures
Information only. Candidacy, technique and outcomes are decided by the operating surgeon. Refractive surgery fees and co-management arrangements must follow federal and state law. Vision Rescue is a licensed pharmaceutical wholesale distributor.
Know the options your surgeons offer.
Patients ask about SMILE by name. A clear, accurate answer keeps them in your practice for the screening and the follow-up.
SMILE, VISUMAX and SMILE pro are trademarks of Carl Zeiss Meditec. Review the device labeling for indications, contraindications and risks.