China NMPA Product Recall - Clear One-Day Soft Hydrophilic Contact Lens

Bausch & Lomb Incorporated, in cooperation with its Chinese subsidiary, initiated a voluntary Class III recall of certain batches of its Clear One-Day Soft Hydrophilic Contact Lenses in China. The recall, reported to the National Medical Products Administration (NMPA) on August 17, 2016, and publicly announced on September 12, 2016, was prompted by a significant packaging mislabeling issue. The outer packaging of the affected lenses incorrectly printed "Usage Period: 1 Month," despite the product being designed and intended as a daily disposable lens. This discrepancy in usage instructions posed a potential risk of consumer misuse, although the recall level was designated Class III, indicating a low probability of adverse health consequences. The affected products were sold between July 11, 2016, and July 26, 2016, with over 210,000 units imported into China. In response, Bausch & Lomb implemented several corrective actions. The company mandated its sales personnel to educate consumers on the correct usage of daily disposable lenses to prevent confusion. Furthermore, Bausch & Lomb committed to reprocessing the outer packaging of all remaining and future products to accurately reflect their daily disposable nature before resuming sales. Customers who purchased the identified batches were advised to return the products.