PURPOSE: To describe complications associated with femtosecond laser-assisted flap creation in LASIK surgery. The management and visual outcomes of femtosecond laser complications related to flap creation in LASIK patients are also described. METHODS: All eyes that underwent LASIK with the IntraLase femtosecond laser from September 2003 to June 2006 at a university-based refractive center were included in this retrospective, noncomparative, interventional case series and IntraLase-related LASIK complications are described. All flaps were made with the 15- and 30-kHz IntraLase femtosecond laser. RESULTS: Included in the study were 4772 eyes, of which 44 (0.92%) eyes had direct or indirect complications due to flap creation. Thirty-two eyes had indirect complications (diffuse lamellar keratitis [DLK] and transient light sensitivity)-20 (0.42%) eyes developed DLK (stage 1 to 2) and 12 (0.25%) eyes had transient light sensitivity syndrome. Twelve (0.25%) eyes had direct femtosecond laser flap-related complications-8 (0.17%) eyes had premature breakthrough of gas through the epithelium within the flap margins, 3 (0.06%) eyes had incomplete flaps due to suction loss, and 1 (0.02%) eye had irregular flap due to previous corneal scar. CONCLUSIONS: Less than 1% of eyes had direct or indirect complications due to femtosecond laser flap creation. Laser in situ keratomileusis complications specifically related to the IntraLase femtosecond laser did not cause loss of best spectacle-corrected visual acuity in any eyes.
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