China NMPA Product Recall - ophthalmic viscoelastic

The National Medical Products Administration (NMPA) announced on June 19, 2017, a voluntary Class II recall initiated by Allergan (Shanghai) Medical Device Trading Co., Ltd. The recall pertains to their Ophthalmic Viscoelastic product, registered under No. 20163223003. This action was prompted by the potential presence of tiny glass particles within the product's solution. As a crucial measure to ensure patient safety and product quality, Allergan (Shanghai) proactively reported this issue to the NMPA. The Class II designation indicates that the use of or exposure to the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has taken responsibility by implementing this voluntary recall to remove affected batches from the market. Further specific details regarding the models, specifications, and batch numbers of the affected ophthalmic viscoelastic products are documented in the comprehensive Medical Device Recall Event Report Form, which supports this regulatory action. This initiative underscores the company's commitment to compliance with NMPA regulations and safeguarding public health.