China NMPA Product Recall - Excimer Laser System

Carl Zeiss Meditec AG has initiated a voluntary recall of its Excimer Laser systems. This action was reported to the National Medical Products Administration (NMPA) in China by Carl Zeiss (Shanghai) Management Co., Ltd. The primary reason for the recall is the inclusion of specific functionalities, namely PRK (laser-assisted refractive keratomileusis) and PTK (therapeutic surface keratomileusis), which have not yet received regulatory approval in Japan for these devices. The recall references National Medical Device Registration Certificates 20153163346 and 20153243346, operating within the NMPA's regulatory framework. While the document does not specify inspection dates, it outlines a proactive measure by the manufacturer to address this regulatory discrepancy. A critical detail for the Chinese market is that the specific products subject to this recall were not imported into China, indicating no direct impact on patients or healthcare providers within the country. The required action is a voluntary withdrawal of these devices, with comprehensive details on affected models, specifications, and batches provided in an accompanying Medical Device Recall Event Report Form. This recall highlights the company's commitment to ensuring product compliance with various regional regulatory standards.