China NMPA Product Recall - Soft hydrophilic contact mirror

On July 23, 2019, CooperVision Products Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its soft hydrophilic contact lenses. This action followed a 2019 national medical device sampling inspection, during which the National Medical Products Administration (NMPA) identified that two product batches failed to meet the national mandatory standards for total diameter. The affected products are soft hydrophilic contact lenses, registered under CFDA (Imported) 2014 No. 3222816, with oversight from the Shanghai Food and Drug Administration. CooperVision undertook this recall proactively after the non-compliance was discovered through the routine regulatory oversight process. A Class III recall signifies that exposure to the product is not expected to cause adverse health consequences. Detailed information concerning the models, specifications, and specific affected batch numbers is provided in the associated "Medical Device Recall Event Report Form." This voluntary recall highlights the company's dedication to product safety and adherence to national medical device regulations following standard quality assurance assessments.