China NMPA Product Recall - COMPACT INTUITIV System for Ophthalmic Phacoemulsification Therapy

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Johnson & Johnson Surgical Vision, Inc. on June 16, 2022. This recall addresses specific models and batches of their COMPACT INTUITIV System for Ophthalmic Phacoemulsification Therapy. The core issue leading to this action is the compromised sterile barrier of the device's dust cover, which poses a significant concern for product integrity and patient safety. Allergy Care (Shanghai) Medical Device Trading Co., Ltd. reported the problem that prompted the manufacturer's decision. This action is undertaken within the regulatory framework of the NMPA, with the Class II designation indicating a moderate risk level associated with the defect. While specific inspection dates are not detailed in this recall notice, the immediate required action is the voluntary removal of all affected products from the market. Further comprehensive details regarding the specific batches and product identifiers are provided in the attached Medical Device Recall Event Report Form, ensuring full transparency in the recall process.