中国药物警戒 ›› 2012, Vol. 9 ›› Issue (11): 679-680.

• 药械安全性研究 • 上一篇    下一篇

试论人工晶体的临床风险及控制措施

赵玉娟1, 赵燕2, 丁红2*   

  1. 1 山东省药品不良反应监测中心,山东 济南 250013；
    2 国家食品药品监督管理局药品评价中心,北京100045；
    3 武警总医院,北京 100039
  • 收稿日期:2012-06-19 出版日期:2012-11-10 发布日期:2015-08-07
  • 通讯作者: 丁红,女,硕士,中西医结合。E-mail: wjdinghong@163.com
  • 作者简介:赵玉娟,女,硕士,生物医学工程。

Clinical Risks and Control Measures of Intraocular lens

ZHAO Yu-juan1, ZHAO Yan2, DING Hong2*   

  1. 1 Adverse drug reaction monitoring center of Shandong, Shandong Jinan 250013;
    2 Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    3 General Hospital of Armed Police Force, Beijing 100039
  • Received:2012-06-19 Online:2012-11-10 Published:2015-08-07

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摘要： 随着人工晶体设计和制造工艺的改进以及手术技术的不断完善和提高,人工晶体手术相关并发症已逐渐减少,但仍然存在着影响手术患者预后的风险因素。通过介绍人工晶体常见的不良事件表现,并从医疗器械不良事件监测角度着重对由晶状体本身质量或材质问题导致的人工晶体不良事件及其可能原因进行分析,以期为临床正确、安全使用人工晶体提供参考。

关键词: 人工晶体, 医疗器械不良事件, 风险控制

Abstract: With the improvements of surgical techniques and intraocular lens(IOL) design and manufacturing, operative complications of IOL surgery have been gradually reduced, but there are still risk factors affecting the postoperative prognosis. This article describes the common adverse events of IOL, and focuses on the adverse events caused by the quality or materials of IOL and their possible causes, which provides a reference for correct and safe use of IOL on clinic.

Key words: intraocular lens, medical device adverse event, risk control