399例软性角膜接触镜可疑医疗器械不良事件报告分析  

Analysis of 399 Cases of Medical Devices Adverse Events Induced by Soft Contact Lenses

作　　者：李穗 徐玉茗 詹杨 余超 罗培 LI Sui;XU Yu-ming;ZHAN Yang;YU Chao;LUO Pei(Jiangxi Drug Adverse Reaction Monitoring Center,Jiangxi Nanchang 330046)

机构地区：[1]江西省药品不良反应监测中心,江西南昌330046

出　　处：《中国医疗器械信息》2020年第23期12-13,25,共3页China Medical Device Information

基　　金：江西省药品监督管理局科研项目(项目编号:2019JS29)。

摘　　要：目的:分析软性角膜接触镜不良事件的特点,为用镜安全提供参考。方法:对2010年~2018年江西省药品不良反应监测中心收集的399例不良事件报告统计分析。结果:女性人数是男性的2.30倍;不良事件主要伤害表现为眼部不适、眼部病变,器械故障主要表现为镜片损坏;77位需药物治疗的配戴者未去医疗机构诊治;配戴行为不当与不良事件发生具有很强的关联性。结论:软性角膜接触镜存在较高的风险,监督管理部门需加强监督管理,保障用镜的安全。Objective:To analyze the characteristics of medical devices adverse events of soft contact lenses,to provide reference for public safety of using.Methods:399 medical devices adverse events reports of soft contact lenses collected by Jiangxi Adverse Drug Reaction Monitoring Center from 2010 to 2018,were statistically analyzed.Results:Female were 2.30 times that of male.The main injuries of adverse events were eye discomfort symptoms,eye lesions,and,device failure was mainly manifested as lens damaged;Seventy-seven wearers needed medical treatment,did not visit the medical institution.There was a strong correlation between inappropriate wearing behavior and adverse events.Conclusion:Soft contact lenses have high risks,supervision and management departments must strengthen supervision and management to ensure the safety of lens.

关 键 词：软性角膜接触性 不良事件 分析 

分 类 号：TH786[机械工程—仪器科学与技术]