China NMPA Product Recall - Soft contact lenses (brand name: Sooto Astigmatism), Soft contact lenses (brand name: Moisture Relief)

On April 11, 2019, Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its soft contact lenses, sold under the trade names Sooton Astigmatism and Mooton. This action, reported to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, was prompted by multiple complaints received from the Japanese market. The core issue identified involved the presence of visible plastic foreign objects found within the sealed plastic packaging of the lenses, specifically inside the packaging with aluminum foil caps. The affected products are identified by Registration Certificate Nos.: CFDA (Imported) 2014 No. 3223877 and CFDA (Imported) 2014 No. 3224713. While the document specifies a voluntary recall, it indicates that comprehensive details regarding the precise models, specifications, and batch numbers of the impacted devices are available in an attached "Medical Device Recall Event Report Form." This proactive measure by Johnson & Johnson Vision Care demonstrates compliance with regulatory expectations for addressing product quality concerns and ensuring consumer safety within the medical device industry under the oversight of Chinese regulatory bodies.