Intraoperative And Postoperative Complications Of Smile Pro (Visumax 800): Early And Late Outcomes
Published 2026 - 44th Congress of the ESCRS
Reference: PP22.07 | Type: Free paper | DOI: 10.82333/bsqq-vq98
Authors: Dr Lena Beckers* 1 , Dr David Beckers 1 , Dr Florian Kretz 1 , Dr Mücella Kirca 2 , Dr Karsten Klabe 2 , Dr Hakan Kaymak 2 , Dr Detlev Breyer 2
1Precise Vision,Rheine,Germany, 2Breyer Kaymak Klabe,Duesseldorf,Germany
Purpose
To report intraoperative safety and postoperative complications after small-incision
lenticule extraction (SMILE) using the 2-MHz femtosecond platform (SMILE Pro; VisuMax 800) in routine
practice.
Setting
All surgeries were / will be performed at the Breyer-Kaymak-Klabe Eye Surgery and
Premium Eyes in Duesseldorf, Germany, member of the International Vision Correction Research
Center (IVCRC.net) by one single surgeon (Breyer). Baseline age was 32.9 ± 6.9 years; average preoperative refraction was −3.60 ± 1.90/−0.87 ±0.76 D (sphere/cylinder) with best corrected visual acuity of −0.08 ± 0.07 logMAR.
Methods
Retrospective consecutive case series at a single center. All planned SMILE Pro procedures
were analyzed (916 eyes from 482 patients). Outcomes included completion rate, intraoperative
events, postoperative complications stratified as <3 and >3 months, and retreatment rate.
Results
Procedures were completed in 911/916 eyes (99.45%). Suction loss occurred in 6 eyes (0.66%); one was completed
after redocking, four were converted (two ICL, two femtosecond LASIK) and one did not receive a
second procedure. No failed lenticule separations occurred. Retreatment was performed in 14 eyes
(1.54%): 11 re-LASIK, two ICL, and one cataract extraction. Early postoperative events (<3 months)
were mainly superficial punctate keratitis (3.51%) and mild dry eye (1.32%); beyond 3 months, events
remained uncommon (mild dry eye 1.65%, photopsia/halo/glare (0.88%) not leading to inability to
drive a car at night time). No severe or sight-threatening complications were observed.
Conclusions
SMILE Pro on the VisuMax 800 showed a high completion rate, rare intraoperative
disruption, low retreatment, and infrequent, mostly mild postoperative events. Dry Eye or photopsia
equal the normal population and did not show a higher incidence. These findings support a favorable
safety profile in routine practice; longer-term follow-up is warranted.