China NMPA Product Recall - Intraocular lens implant

Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its intraocular lens implants (IOLs), as announced by the National Medical Products Administration (NMPA) on June 19, 2017. This regulatory action pertains to IOLs registered under National Medical Device Registration Certificate No. 20142045599. While the specific reasons prompting the recall are not detailed in this public notice, a voluntary recall at Class II level typically signifies a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company proactively removed the affected medical devices from the market to ensure patient safety and maintain product integrity. Full particulars concerning the models, specifications, and batch numbers of the implicated products are contained within the 'Medical Device Recall Event Report Form,' which accompanies the official NMPA announcement. This recall underscores the rigorous regulatory oversight exercised by the NMPA over medical devices in China, ensuring that companies adhere to strict quality and safety standards for products available to the public. Bausch & Lomb's voluntary action reflects its commitment to compliance with national medical device regulations and patient well-being, under the framework of NMPA's comprehensive supervision.