China NMPA Product Recall - Polyacrylate posterior chamber intraocular lenses (trade name: Sensar), foldable posterior chamber acrylic intraocular lenses (trade name: Tecnis)

Allergan (Shanghai) Medical Devices Trading Co., Ltd., the China-based responsible unit for products manufactured by Abbott Medical Optics Inc., initiated a Class II voluntary recall of specific intraocular lenses (IOLs), including Sensar AR40e and Tecnis ZCB00 models. This recall, reported to the National Medical Products Administration (NMPA) on September 5, 2016, and publicly announced on December 7, 2016, was prompted by the discovery of a malfunction in a testing device. This malfunction resulted in certain IOLs not undergoing all required quality checks before release, potentially leading to incorrect product labeling. The primary concern is that using an incorrectly labeled IOL could cause unintended postoperative refractive errors in adult patients, potentially necessitating further surgical intervention. Under the NMPA's regulatory framework, Allergan Shanghai directed all distributors to contact customers, stop shipments and use of any remaining unimplanted stock, and facilitate the return of these affected lenses. IOLs already implanted and functioning effectively are not impacted by this recall action.