Adverse Events of Femtosecond-Assisted Laser-Assisted In situ Keratomileusis: A Manufacturer and User Facility Device Experience Database Study.

IF 1.2 Q3 OPHTHALMOLOGY
Journal of Current Ophthalmology Pub Date : 2024-08-10 eCollection Date: 2023-10-01 DOI:10.4103/joco.joco_164_23
Sungmin Hong, Austin Yu, Amanda Wong, Richard Adamovich-Zeitlin, Paras Shah, Josue Minaya, Carol Wang, Travis Peng, Matthew Saleem, Nathan Lau, Rohun Gupta, Matthew Gorski, Jules Winokur, Daniel Zhu
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引用次数: 0

Abstract

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.

飞秒激光辅助原位角膜磨镶术的不良事件:制造商和用户机构设备经验数据库研究》。
目的:分析美国食品和药物管理局的制造商和用户设施设备经验(MAUDE)数据库(其中包含涉及医疗设备的不良事件报告),并描述飞秒激光辅助原位角膜磨镶术(LASIK)最常见的不良事件:于2022年5月19日查询了MAUDE数据库,以了解2012年1月至2022年4月期间报告的涉及眼科飞秒激光的不良事件。排除了与 LASIK 手术无关的报告。对这些报告进行了数据提取,包括不良事件的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:在涉及 FS 激光系统的 3491 例不良事件报告中,有 1136 例符合纳入标准。在报告结果的 672 个病例中,476 例成功完成手术,196 例流产。最常见的术中并发症是切割不完整(42.8%)、皮瓣比预期的薄(17.6%)和皮瓣掀起困难(12.0%)。FS相关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下降(10.2%)、对接困难(2.4%)和激光故障(2.0%)。最常见的术后并发症是弥漫性板层角膜炎(DLK)(7.8%)和彩虹眩光(4.6%):结论:在MAUDE数据库中,最常见的FS辅助LASIK术中并发症是角膜瓣不完整。结论:MAUDE数据库中最常见的FS辅助LASIK术中并发症是角膜瓣不完整,最常见的术后并发症是DLK。这项研究首次调查了MAUDE数据库中FS辅助LASIK的不良事件。它可以提高人们对现实世界中手术并发症的认识,帮助眼科医生更好地为患者提供咨询和治疗。
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来源期刊
CiteScore
2.50
自引率
6.70%
发文量
45
审稿时长
8 weeks
期刊介绍: Peer Review under the responsibility of Iranian Society of Ophthalmology Journal of Current Ophthalmology, the official publication of the Iranian Society of Ophthalmology, is a peer-reviewed, open-access, scientific journal that welcomes high quality original articles related to vision science and all fields of ophthalmology. Journal of Current Ophthalmology is the continuum of Iranian Journal of Ophthalmology published since 1969.
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