Hong Sungmin, Yu Austin, Wong Amanda, Adamovich-Zeitlin Richard, Shah Paras, Minaya Josue, Wang Carol, Peng Travis, Saleem Matthew, Lau Nathan, Gupta Rohun, Gorski Matthew, Winokur Jules, Zhu Daniel
Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.
Drexel University College of Medicine, Philadelphia, Pennsylvania, USA.
J Curr Ophthalmol. 2024 Aug 10;35(4):350-354. doi: 10.4103/joco.joco_164_23. eCollection 2023 Oct-Dec.
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 keratomileusis (LASIK).
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.
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%).
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.
分析美国食品药品监督管理局的制造商和用户设施设备经验（MAUDE）数据库，该数据库包含涉及医疗器械的不良事件报告，并描述飞秒（FS）激光辅助角膜原位磨镶术（LASIK）最常见的不良事件。
于2022年5月19日查询MAUDE数据库，以获取2012年1月至2022年4月期间报告的涉及眼科FS激光的不良事件。排除与LASIK手术无关的报告。对这些报告进行数据提取，包括不良事件类型以及手术是否成功完成。使用社会科学统计软件包进行频率分析。
在3491例报告的涉及FS激光系统的不良事件中，1136例符合纳入标准。在报告结果的672例病例中，476例手术成功完成，196例手术中止。最常见的术中并发症为切割不完全（42.8%）、瓣比预期薄（17.6%）和瓣掀起困难（12.0%）。与FS相关的并发症包括不透明气泡层（2.3%）、前房气泡（2.4%）和垂直气体突破（4.1%）。其他与设备相关的术中并发症包括吸力丧失（10.2%）、对接困难（2.4%）和激光故障（2.0%）。最常见的术后并发症为弥漫性层间角膜炎（DLK）（7.8%）和虹视眩光（4.6%）。
MAUDE数据库中最常见的术中FS辅助LASIK并发症为瓣制作不完全。最常见的术后并发症为DLK。本研究首次在MAUDE数据库中调查FS辅助LASIK不良事件。它可以提高对实际手术并发症的认识，并帮助眼科医生更好地为患者提供咨询和治疗。
