China NMPA Product Recall - WHITESTAR Signature Phacoemulsification System

The National Medical Products Administration (NMPA) published a recall notice on September 18, 2021, concerning a voluntary Class III recall initiated by Johnson & Johnson Surgical Vision, Inc. This recall, issued through Allergan (Shanghai) Medical Devices Trading Co., Ltd., pertains to specific models and batches of the WHITESTAR Signature Phacoemulsification System. The core issue stems from an unapproved minor raw material design change that was submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in February 2017. Despite the lack of regulatory approval from the PMDA for this modification, products incorporating the change appear to have entered distribution. As a result, Johnson & Johnson Surgical Vision, Inc. is now voluntarily recalling these affected medical devices to ensure compliance with regulatory standards. This action underscores the necessity of securing all required regulatory clearances for any design alterations to medical products before manufacturing or distribution. Further detailed information, including specific models, specifications, and batch numbers of the affected products, is available in the accompanying "Medical Device Recall Event Report Form."