Adverse Events of Femtosecond-Assisted LASIK: A MAUDE Database Study

Abstract

Purpose : Laser-assisted in situ keratomileusis (LASIK) is a popular alternative to glasses and contact lenses for refractive correction. The majority of LASIK procedures in the United States (US) are performed with the femtosecond (FS) laser system, which offers several advantages over the conventional microkeratome technique. To our knowledge, no study has analyzed the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices, to characterize the most common adverse events of FS-assisted LASIK.

Methods : The MAUDE database was queried on May 19, 2022 for adverse events involving the ophthalmic FS laser reported from January 2012 - April 2022. Reports of adverse events unrelated to LASIK procedures were excluded. Data extraction was performed on these reports, including the type of adverse event and whether surgery was successfully completed. Frequency analysis was performed using Statistical Package for the Social Sciences.

Results : From the 3491 reported adverse events involving the FS laser system, 1246 met inclusion criteria. Of the 803 cases where the outcomes were reported, 75.2% were successfully completed and 24.8% were aborted. The most frequently reported intraoperative complications were incomplete cut (38.0%), thinner than intended flap (15.7%), and difficulty lifting the flap (12.9%). FS-related complications included opaque bubble layer (2.7%), air bubbles in the anterior chamber (2.1%), and vertical gas breakthrough (2.0%). Other device-related intraoperative complications included suction loss (10.2%) and unintended gantry movement (6.3%). The most common postoperative complications were diffuse lamellar keratitis (DLK) (6.1%) and rainbow glare (4.3%).

Conclusions : The most common intraoperative FS-assisted LASIK complication reported to the MAUDE database was an incomplete cut of the flap and the most common postoperative complication was DLK. This is the first study using the MAUDE database to investigate FS-assisted LASIK adverse events. These findings can enhance awareness of real-world surgical complications and help ophthalmologists better counsel and treat patients.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.