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

Johnson & Johnson Vision Care Inc. initiated a voluntary Class II recall of its Oushiso Astigmatism soft contact lenses. This action, reported by Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) on March 19, 2019, and published on April 1, 2019, stemmed from an internal investigation at their Jacksonville, U.S. factory. The investigation revealed that a specific batch of "Avisop" Astigmatism products failed to meet additional packaging sealing test standards, posing a potential quality concern. The affected product, registered under CFDA (Imported) 2014 No. 3224690, is designed to correct refractive errors, including myopia, hyperopia, and astigmatism up to 4.00D. Despite the recall originating from a manufacturing issue in the United States, Johnson & Johnson Vision Care confirmed that the specific batches identified as failing the packaging sealing tests were not imported into China. Consequently, the Chinese market remains unaffected by this recall event. Given that no compromised products reached China, no corrective actions or further measures are required from the NMPA or Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd. within the Chinese jurisdiction. The recall was proactively managed by the manufacturer to uphold product integrity, consistent with regulatory expectations for product safety and quality assurance.