China NMPA Product Recall - Lens Fragmentation Device

The National Medical Products Administration (NMPA) announced on May 29, 2025, a voluntary Class III recall initiated by Carl Zeiss Meditec AG, a German manufacturer, concerning its Lens Fragmentation Device. The recall was reported by Carl Zeiss (Shanghai) Management Co., Ltd. The primary reason for this action is non-compliance of the product's labeling with the regulatory requirements of Japan, the importing country. While the NMPA serves as the reporting authority for this recall, the specific violation relates to Japanese regulations governing medical device labeling. The device in question is identified by National Medical Device Registration Certificate No. 20222160413. It is important to note that the affected Lens Fragmentation Devices involved in this particular recall event were not imported into the People's Republic of China, thus Chinese markets are not directly impacted. Further details regarding specific models, specifications, and approval information are available in an attached "Medical Device Recall Event Report Form" from Carl Zeiss Medical Technology (Germany) AG. This proactive measure by Carl Zeiss Meditec AG demonstrates a commitment to adhering to international regulatory standards, ensuring product safety and compliance across diverse markets.