China NMPA Product Recall - Soft hydrophilic contact lenses (trade names: PureVision Multifocal, BROZHEN Pure Solar Disposable)

The National Medical Products Administration (NMPA) announced on September 14, 2015, a voluntary recall initiated by Bausch & Lomb Incorporated for certain soft hydrophilic contact lenses. The recall involved two product lines: PureVision Multifocal (CFDA Import Medical Device (2013) No. 3222567) and Bora Pure Daily Disposable, also known as Bausch & Lomb Daily Disposable Lens (CFDA Import Medical Device (2014) No. 3224563).

The primary reason for the recall was the discovery of minor defects on the optical surface of a small number of lenses during internal investigations. Specifically, -6.00D high-powered PureVision Multifocal lenses and -2.25D Bora Pure Daily Disposable lenses were found to have these imperfections. While Bausch & Lomb determined these defects were unlikely to cause significant incidents, the company initiated the recall to uphold its stringent quality standards.

Under the NMPA's regulatory oversight, the company confirmed that all affected product batches had not been imported or sold within mainland China. Consequently, this recall had no direct impact on the Chinese market or consumers. The NMPA instructed relevant provincial food and drug administrations to enhance their supervision and management of similar medical devices.