China NMPA Product Recall - Optometry

Shanghai Chang'e Optical Instrument Technology Co., Ltd. initiated a voluntary Class III recall of its optometrist instruments, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on November 25, 2020. The recall was prompted by significant product integrity concerns. The primary issues identified included the inability to effectively trace equipment due to the replacement of serial numbers following repairs, which complicated tracking the product's history and original specifications. Additionally, the company recognized that extending the service life of these medical devices contributed to the safety concerns. This voluntary action, outlined in the "Medical Device Recall Event Report Form" and affecting instruments with Registration Certificate No.: 沪械注准20162220544, demonstrates the company's compliance within the regulatory framework overseen by the NMPA. The required action is a comprehensive recall of the affected models, specifications, and batches to mitigate potential risks associated with the traceability and extended use issues.