Adverse Events Associated with Femtosecond Laser-Assisted Cataract Surgery Reported to the FDA MAUDE Database.
Academic Article
Overview
abstract
PURPOSE: To report real-world complications associated with femtosecond laser-assisted cataract surgery (FLACS). SETTING: De-identified database. DESIGN: Retrospective review of adverse events associated with FLACS reported to the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. METHODS: The MAUDE database was culled for adverse events involving ophthalmic femtosecond laser during cataract surgery from January 2010 to January 2020. Reports in which the narrative description was inadequate to determine the nature of the complication were excluded. Each report was reviewed for complications, which were subsequently assigned to a complication category as determined by these authors. The number of events per year was determined and compared. RESULTS: Between January 2010 and January 2020, the MAUDE database search yielded 2,927 reports involving femtosecond laser, of which 1,927 met inclusion criteria and were included for analysis. These reports revealed 2,704 complications: 1,115 capsule tears (41.2%), 329 of which required vitrectomy, 372 instances of suction loss, 321 other capsulotomy-related complications, and 432 corneal or incisional complications. Rare complications included 54 reports of miosis, 16 reports of endophthalmitis, and 4 reports of toxic anterior segment syndrome. The number of events in the MAUDE database increased year over year between 2011 and 2017, peaking in 2017 at 303 events. CONCLUSIONS: By drawing on real-world data in the MAUDE database, this study identifies the complications of greatest importance in clinical practice. Surgeons should be aware of the spectrum of possible complications in order to best prepare for all potential outcomes and to effectively counsel patients.
