China NMPA Product Recall - Soft hydrophilic contact mirror

On July 26, 2019, Shitong (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its soft hydrophilic contact lenses. This action stemmed from a 2019 national random inspection, which revealed that the total diameter of some manufactured products did not meet the established product registration standards. The affected contact lenses are identified under Registration Certificate No. 国械注进20173226534. This recall is overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, aligning with China's robust regulatory framework for medical devices. A Class III recall indicates that the product defect, while a deviation, is unlikely to cause significant adverse health consequences. Shitong (Shanghai) Trading Co., Ltd. is responsible for implementing this recall to address the non-compliance. Further specific details regarding the models, specifications, and batch numbers of the impacted products are contained within the "Medical Device Recall Event Report Form," serving as the official documentation for this event. This voluntary market action demonstrates the company's commitment to correcting product quality deviations identified through regulatory surveillance, ensuring adherence to medical device standards and product integrity.