Intraoperative Safety and Postoperative Complications After SMILE Pro: A Retrospective Case Series of 916 Eyes

Purpose: To report intraoperative safety and postoperative complications after small-incision lenticule extraction using the 2 MHz femtosecond platform (SMILE Pro; VisuMax 800) in routine practice. 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: 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. Procedures were completed in 911 of 916 eyes (99.45%). Suction loss occurred in six 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, 2 ICL, and 1 cataract extraction. Early postoperative events (<3 months) were mainly superficial punctate keratitis (3.51%) and dry eye (1.32%); beyond 3 months, events remained uncommon (dry eye 1.65%, photopsia/halo/glare 0.88%). 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 rare, mostly mild postoperative events. These findings support a favorable early safety profile in routine practice; longer-term follow-up is warranted.