China NMPA Product Recall - LAMINAR laminar flow phacoemulsification probe and infusion cannula

Johnson & Johnson Surgical Vision, Inc., with reporting facilitated by Allergan (Shanghai) Medical Device Trading Co., Ltd., has commenced a voluntary Class II recall concerning its Disposable LAMINAR Laminar Phacoemulsification Probes and Infusion Cannulas. This action, formally recorded by the National Medical Products Administration (NMPA) under Index No. JGXX-2023-10042 and publicized on March 14, 2023, stems from the critical issue of expiration affecting specific models and batches of these medical devices. The company's decision underscores a commitment to patient safety and maintaining product integrity, acknowledging that the use of expired devices could potentially compromise clinical outcomes. The regulatory context for this recall is established by the NMPA's stringent medical device oversight, with a Class II classification signifying that while the probability of serious adverse health consequences is remote, the use of or exposure to these products may lead to temporary or medically reversible adverse health impacts. As part of the required actions, Johnson & Johnson Surgical Vision, Inc. must furnish comprehensive details, including product models, specifications, and batch numbers, via the Medical Device Recall Event Report Form. This proactive recall initiative is a testament to the company's adherence to quality assurance protocols and compliance with prevailing medical device regulations, ensuring that healthcare providers and patients receive only safe and effective products.