China NMPA Product Recall - Glass cutter

The National Medical Products Administration (NMPA) issued a notice concerning a voluntary product recall initiated by Abbott Medical Optics Inc. The recall, reported on April 21, 2017, pertains to specific vitrectomy blades distributed in China by Allergan (Shanghai) Medical Device Trading Co., Ltd. The main issue identified was a potential packaging error, where 20GA and 25GA glass cutters, critical components of ophthalmic phacoemulsification devices, may have been inadvertently mixed. These blades are single-use tools for removing vitreous humor and are intended for use with the AMO WHITESTAR SIGNATURE system. The product is regulated under CFDA (Imported) Registration Certificate No. 20133234023. Abbott Medical Optics Inc. confirmed that the affected batches were not sold or imported into China. Therefore, no direct corrective actions are required within China concerning the recalled products. However, the NMPA requested all provincial Food and Drug Administrations to strengthen their oversight and management of similar medical devices to ensure public safety.