AIM:To investigate the safety and complications of femtosecond laser corneal small incision lenticule extraction(SMILE)procedure and discuss the prevention and treatment.

METHODS: We retrospectively studied the complications of 403 patients(799 eyes)with myopia and myopic astigmatism treated by SMILE.

RESULTS: All the patients underwent the operation successfully. Only 1 case(1 eye)suffered from dark spot and changed to femtosecond laser-assisted LASIK(FS-LASIK), 5 cases(5 eyes, 0.6%)suffered from the suction loss, 11 cases(17 eyes, 2.1%)developed opaque bubble layer. All patients gained perfect uncorrected visual acuity(UCVA)(20/20). The best corrected visual acuity(BCVA)did not decrease after operations. The incidence of haze and diffuse lamellar keratitis was low(0.3% and 0.4%, respectively)and no other complications were observed. There was 9 eyes in 6 patients(1.1%)found regression of refraction at 6mo after surgery, while the UCVA of rest patients reached 1.0 at 3mo after surgery.

CONCLUSION: The SMILE procedure has high safety for myopia and myopic astigmatism. Effective prevention and management of the complications is the key to achieve the satisfactory visual acuity.