China NMPA Product Recall - Soft contact lenses (brand name: Oushusu Astigmatism)

Johnson & Johnson Vision Care Inc., through its agent Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall for its "Oushiso Astigmatism" soft contact lenses (Registration No.: CFDA (Imported) 2014 No. 3224690). This recall, reported on March 19, 2019, and published by the National Medical Products Administration (NMPA) on March 27, 2019, was prompted by an internal investigation at the company's Jacksonville, U.S. factory. The investigation revealed that a specific batch of these contact lenses failed to meet additional packaging sealing test standards, indicating a potential issue with product integrity. While the manufacturer undertook this voluntary corrective action under NMPA oversight, the "Medical Event Report Form" confirmed that the affected batch numbers were never imported into the Chinese market. Consequently, the Chinese market is entirely unaffected, and no specific corrective actions are required within China for consumers or distributors. The recall's primary scope targets regions, such as the United States, where the non-conforming products were distributed, demonstrating the company's commitment to product quality and safety.