China NMPA Product Recall - Optometry

On August 17, 2020, Shanghai Chang'e Optical Instrument Technology Co., Ltd. initiated a voluntary Class III recall of its manufactured optometristors. This action follows a national sampling inspection where the product failed the durability test of the equipment marking. The recall was reported by the Shanghai Municipal Drug Administration, operating under the regulatory oversight of the National Medical Products Administration (NMPA). The affected medical devices, registered under certificate number "沪械注准20162220544," are subject to this recall due to the identified quality control issue. A Class III recall typically signifies a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The company is taking proactive steps to address the non-conformity discovered during the inspection. Detailed information regarding the specific models, specifications, and batch numbers of the recalled optometristors is available in the "Medical Device Recall Event Report Form," which accompanies the official announcement. This voluntary recall underscores the manufacturer's commitment to product safety and compliance with regulatory standards, ensuring that medical devices meet the required performance and labeling criteria.