China NMPA Product Recall - Intraocular lens

The National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Johnson & Johnson Surgical Vision, Inc., regarding certain TECNIS® intraocular lenses. The recall, reported by Allergan (Shanghai) Medical Device Trading Co., Ltd. on July 26, 2023, addresses a manufacturing issue where non-astigmatic intraocular lenses were found to possess astigmatic correction reference marks. This deviation from product specifications impacts the integrity and intended use of these medical devices. The affected products are registered under National Medical Device Registration Certificate No. 20233160195. A Class II recall indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Johnson & Johnson Surgical Vision, Inc. is taking the required action of a voluntary recall to ensure patient safety and product quality. Specific details concerning the models, specifications, and batch numbers of the involved intraocular lenses are documented in an accompanying "Medical Device Recall Event Report Form." This action underscores the commitment of the companies and the NMPA to upholding medical device safety standards and addressing manufacturing discrepancies promptly to protect public health.