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Adverse Events of Femtosecond-Assisted Laser-Assisted In situ Keratomileusis: A Manufacturer and User Facility Device
Sungmin Hong1, Austin Yu2, Amanda Wong3
1Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
Purpose:
To analyze the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database, which contains reports of adverse events involving medical devices, and characterize the most common adverse events of femtosecond (FS) laser-assisted in situ keratomileusis (LASIK).
Methods:
The MAUDE database was queried on May 19, 2022, for adverse events involving the ophthalmic FS laser reported from January 2012 to April 2022. Reports 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 the Statistical Package for the Social Sciences.
Results:
From the 3491 reported adverse events involving the FS laser system, 1136 met the inclusion criteria. Of the 672 cases where outcomes were reported, 476 were successfully completed and 196 were aborted. The most common intraoperative complications were incomplete cut (42.8%), thinner than intended flap (17.6%), and difficulty lifting the flap (12.0%). FS-related complications included opaque bubble layer (2.3%), air bubbles in the anterior chamber (2.4%), and vertical gas breakthrough (4.1%). Other device-related intraoperative complications included suction loss (10.2%), difficulty docking (2.4%), and laser malfunction (2.0%). The most common postoperative complications were diffuse lamellar keratitis (DLK) (7.8%) and rainbow glare (4.6%).
Conclusion:
The most common intraoperative FS-assisted LASIK complication in the MAUDE database was an incomplete flap. The most common postoperative complication was DLK. This study is the first to investigate FS-assisted LASIK adverse events in the MAUDE database. It can raise awareness of real-world surgical complications and help ophthalmologists better counsel and treat patients.
Insights
The most common intraoperative femtosecond laser-assisted LASIK complication is an incomplete flap, while diffuse lamellar keratitis is the most frequent postoperative issue. This analysis highlights real-world adverse events for improved patient care.
Area of Science:
- Ophthalmology
- Surgical Technology
- Medical Device Safety
Background:
- Femtosecond (FS) laser-assisted in situ keratomileusis (LASIK) is a widely used refractive surgery procedure.
- Adverse events associated with FS-LASIK require ongoing monitoring and analysis to ensure patient safety and optimize surgical outcomes.
Purpose of the Study:
- To analyze the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database for adverse events related to FS-laser-assisted LASIK.
- To characterize the most common intraoperative and postoperative complications associated with this technology.
Main Methods:
- The MAUDE database was queried for ophthalmic FS laser adverse events reported between January 2012 and April 2022.
- Reports were filtered to include only LASIK procedures, and data on adverse event type and surgical outcome were extracted.
- Frequency analysis was conducted using the Statistical Package for the Social Sciences.
Main Results:
- Of 1136 included reports, incomplete flap (42.8%) was the most common intraoperative complication.
- Other intraoperative issues included thinner flap (17.6%), difficulty lifting flap (12.0%), suction loss (10.2%), and laser malfunction (2.0%).
- The most frequent postoperative complication was diffuse lamellar keratitis (DLK) (7.8%), followed by rainbow glare (4.6%).
Conclusions:
- An incomplete flap is the primary intraoperative complication, and DLK is the main postoperative complication in FS-assisted LASIK, based on MAUDE database analysis.
- This study provides valuable insights into real-world FS-LASIK complications, aiding ophthalmologists in patient counseling and management.
- This is the first study to comprehensively investigate FS-assisted LASIK adverse events within the MAUDE database.
