China NMPA Product Recall - TECNIS® Toric 1-Piece IOL - One-Piece Multi-Surface Intraocular Lens

Johnson & Johnson Surgical Vision, Inc., in conjunction with its distributor Allergan (Shanghai) Medical Device Trading Co., Ltd., has initiated a voluntary Level II recall for specific models and batches of its TECNIS® Toric 1-Piece Intraocular Lens (IOL). This action, detailed in a National Medical Products Administration (NMPA) document published on March 3, 2021, addresses a critical quality issue. The recall stems from the accidental distribution of substandard products that may result in insufficient vision correction for patients. This deficiency could potentially necessitate a secondary surgical intervention, thereby posing risks to patient health and imposing additional burdens on healthcare providers. The company is undertaking this recall under the NMPA's regulatory framework to ensure product safety and maintain compliance with established quality standards. Comprehensive details concerning the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form," providing essential information for identifying and managing the recalled devices. This proactive measure underscores the company's commitment to addressing product deficiencies and protecting patient outcomes.