Related Experiment Video
Updated: Oct 26, 2025
Ultrasound Cyclo Plasty in Eyes with Glaucoma
Published on: January 26, 2018
Adverse events associated with femtosecond laser-assisted cataract surgery reported to the MAUDE database
Lisa R Koenig1, Andrew T Duong, Melissa Yuan
1From the Department of Ophthalmology, Weill Cornell Medicine, New York, New York.
Purpose:
To report real-world complications associated with femtosecond laser-assisted cataract surgery (FLACS).
Setting:
Deidentified database.
Design:
Retrospective review.
Methods:
The U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (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 2927 reports involving femtosecond laser, of which 1927 met inclusion criteria and were included for analysis. These reports revealed 2704 complications: 1115 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 identified the complications of greatest importance in clinical practice. Surgeons should be aware of the spectrum of possible complications to best prepare for all potential outcomes and to effectively counsel patients.
Insights
Real-world data reveal common and rare complications of femtosecond laser-assisted cataract surgery (FLACS). Capsule tears and suction loss were most frequent, emphasizing the need for surgeon awareness and patient counseling regarding FLACS risks.
Area of Science:
- Ophthalmology
- Surgical Technology
- Medical Device Safety
Background:
- Femtosecond laser-assisted cataract surgery (FLACS) offers precision but carries potential complications.
- Understanding real-world adverse events is crucial for patient safety and surgical technique refinement.
Purpose of the Study:
- To comprehensively analyze and report the spectrum of real-world complications associated with femtosecond laser-assisted cataract surgery (FLACS).
Main Methods:
- Retrospective review of deidentified data from the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.
- Analysis of adverse events involving ophthalmic femtosecond lasers during cataract surgery from January 2010 to January 2020.
- Categorization of identified complications and trend analysis of event reporting over time.
Main Results:
- A total of 1927 reports met inclusion criteria, detailing 2704 complications between 2010 and 2020.
- The most frequent complications included capsule tears (41.2%), suction loss (13.7%), and capsulotomy-related issues (11.8%).
- Corneal and incisional complications (16.0%) and rare events like miosis, endophthalmitis, and toxic anterior segment syndrome were also documented, with a peak in reported events in 2017.
Conclusions:
- Real-world data from the MAUDE database highlight significant complications in FLACS, particularly capsule tears and suction loss.
- Surgeons must be aware of the full range of potential FLACS complications to optimize patient preparation and informed consent.
- Continuous monitoring of adverse events is essential for improving the safety and efficacy of femtosecond laser technology in cataract surgery.
