中国药物警戒 ›› 2012, Vol. 9 ›› Issue (6): 354-356.

• 药械安全性研究 • 上一篇    下一篇

角膜接触镜可疑不良事件监测及风险分析

赵燕，郑立佳，董放*   

  1. 国家药品不良反应监测中心，北京 100045
  • 收稿日期:2012-02-05 出版日期:2012-06-10 发布日期:2015-08-10
  • 通讯作者: 董放,男,硕士,高级工程师,医疗器械不良事件监测。E-mail:dongfang@cdr.gov.cn
  • 作者简介:赵燕，女，硕士，医疗器械不良事件监测。

The Medical Device Adverse Events Monitoring and Primary Analysis on Corneal Contact Lens

ZHAO Yan, ZHENG Li-jia, DONG Fang*   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2012-02-05 Online:2012-06-10 Published:2015-08-10

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摘要： 通过介绍角膜接触镜的分类，材料特性及其用常见用途，临床使用现状，常见的可疑医疗器械不良事件及可能原因分析，从材料因素、患者自身因素、使用因素几个方面分析了角膜接触镜常见的风险因素，并给出了初步的风险控制建议。为加强对此类产品的监管，确保角膜接触镜的安全正确使用提供参考。

关键词: 角膜接触镜, 医疗器械不良事件监测, 风险因素, 分析

Abstract: By introducing the classification, material properties, common use, suspected medical device adverse event(MDR) and analysis of the MDR causes of corneal contact len, to analyze the risk factor of corneal contact lens. The analysis of the risk factor is based on three aspects, they are material factor, patients factor and use factor. By giving some advices on the risk control, so as to strengthen the monitoring of this product, and then to ensure the correct and safe use of corneal contact lens.

Key words: corneal contact lens, medical device adverse events monitoring, risk factor, analysiscorneal contact lens, medical device adverse events monitoring, risk factor, analysis