China NMPA Product Recall - Femtosecond laser corneal refractive surgery machine

Carl Zeiss (Shanghai) Management Co., Ltd. initiated a voluntary Level III recall of its femtosecond laser corneal refractive surgery machine, as reported by the National Medical Products Administration (NMPA) on July 5, 2019. The recall stems from customer feedback concerning a product manufactured on November 5, 2018, with batch number S180089. The core issue involved an error in the instruction manual: the registration certificate number printed on the brown outer packaging of the disposable sterile treatment pack incorrectly referenced an outdated medical device registration certificate. This oversight constitutes a defective reference, necessitating corrective action. The regulatory framework overseeing this action includes the NMPA and the Shanghai Food and Drug Administration, which issued the relevant medical device registration certificate. Carl Zeiss (Shanghai) Management Co., Ltd. proactively reported this issue and commenced the recall to address the discrepancy. The required action is the comprehensive retrieval of all affected units of the femtosecond laser corneal refractive surgery machine (Registration Certificate No.: 国械注进20183241728). This voluntary recall ensures compliance with regulatory standards and rectifies the identified documentation error, upholding product integrity and user confidence.