China NMPA Product Recall - Soft hydrophilic contact mirror

Bausch & Lomb Incoporated, through its Chinese subsidiary Beijing Bausch & Lomb Eye Care Products Co., Ltd., initiated a Class III voluntary recall of certain soft hydrophilic contact lenses. The recall, reported to the National Medical Products Administration (NMPA) on August 17, 2016, and publicized on September 12, 2016, primarily addresses a labeling error. The core issue involved the additional printing of "Usage Period: 1 Month" on the outer packaging of Bausch & Lomb Clear One-Day Soft Hydrophilic Contact Lenses. These lenses are designed for daily disposable use, making the "1 Month" text misleading and potentially hazardous if consumers extended usage beyond one day. The affected products were sold in China between July 11, 2016, and July 26, 2016, totaling 211,541 units. Under the NMPA's regulatory framework for medical device recalls, Bausch & Lomb implemented corrective actions. Customers who purchased the specified batches were advised to return them. Furthermore, the company committed to reprocessing the incorrect outer packaging before continued sales. Sales personnel were also instructed to reinforce proper usage instructions to consumers when selling daily disposable products, emphasizing the critical importance of adhering to the intended single-day use to ensure eye health and safety.