China NMPA Product Recall - ophthalmic scalpel

The National Medical Products Administration (NMPA) announced on May 8, 2017, that Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of specific ophthalmic surgical knives. This action stemmed from a quality concern identified through a small number of complaints received from overseas markets, indicating a potential issue with the blades being dull. This voluntary recall addresses a potential product defect where the surgical instruments may not perform as intended during medical procedures. Under the regulatory framework of the NMPA, a Class III recall signifies a situation where the use of, or exposure to, the affected product is not likely to cause adverse health consequences. The company's required action is to retrieve the relevant product batches from the market. Comprehensive details regarding the model, specifications, and batch numbers of the recalled ophthalmic surgical knives are documented in the "Medical Device Recall Event Report Form" attached to the NMPA's official announcement.