China NMPA Product Recall - Soft contact lens

On March 18, 2022, CooperVision Products Trading (Shanghai) Co., Ltd. announced a voluntary recall initiated by its manufacturer, CooperVision Inc. This action pertains to specific models and batches of Soft Contact Lenses, identified under Registration Certificate No.: 20153162423. The primary issue prompting the recall is the discovery of foreign objects within the blister packaging of these affected products. This finding raises concerns regarding product quality and potential implications for user safety. The recall, classified as Class III, indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The National Medical Products Administration (NMPA) in China is the regulatory authority overseeing this event, publishing the official announcement on its website. While specific inspection dates are not detailed, the recall serves as a corrective measure following the identification of this packaging anomaly. CooperVision Inc. is undertaking this voluntary action to address the problem, with comprehensive details concerning affected product models, specifications, and batch numbers available in an accompanying "Medical Device Recall Event Report Form." This proactive step aims to mitigate risks associated with the contact lenses and ensure consumer safety in compliance with regulatory standards.