China NMPA Product Recall - Intraocular lens

Carl Zeiss (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its intraocular lenses, as reported by the National Medical Products Administration (NMPA) on December 31, 2020. The primary issue identified was defects in the Chinese labeling on the outer packaging of the affected medical devices. This voluntary action, formally documented under "沪药监械主召2021-004" by the Shanghai Municipal Drug Administration, pertains to products registered under certificate number 国械注进20153222621. The recall indicates the company's commitment to compliance with regulatory standards for medical device labeling in China. While specific inspection dates are not detailed in this recall notice, the company proactively reported the labeling discrepancies. The recall requires Carl Zeiss (Shanghai) Management Co., Ltd. to remove the affected intraocular lenses from the market. Further details regarding the specific models, specifications, and batch numbers of the recalled products are contained within the Medical Device Recall Event Report Form, which stakeholders can access for comprehensive information. This action underscores the NMPA's oversight in ensuring the accuracy and completeness of product information for medical devices distributed within its jurisdiction.