Chinese Journal of Pharmacovigilance ›› 2012, Vol. 9 ›› Issue (6): 354-356.

• Orginal Article • Previous Articles     Next Articles

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

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