China NMPA Product Recall - Soft hydrophilic contact mirror

Bausch & Lomb Incoporated, in collaboration with its subsidiary Bausch & Lomb Eye Care Products Co., Ltd. (Beijing), initiated a voluntary Class III recall of its soft hydrophilic contact lenses (Registration or Filing No.: 20163220370), as announced by the National Medical Products Administration (NMPA) on September 12, 2016. The recall was prompted by a significant packaging error: the outer packaging of the affected contact lenses erroneously included the text 'Usage Period: 1 Month.' This mislabeling constituted the main issue requiring corrective action. The recall operates within the regulatory framework established by the NMPA, which oversees medical device safety and compliance in China. This voluntary action by Bausch & Lomb demonstrates the company's commitment to ensuring product accuracy and adhering to established labeling standards. The document detailing this recall does not specify any inspection dates, focusing instead on the company's self-initiated corrective measure to address the packaging discrepancy. The required actions included the immediate removal of the mislabeled products from the market. Stakeholders, including consumers and distributors, were instructed to consult the 'Medical Device Recall Event Report Form' for precise details on the affected product models, specifications, and batch numbers, facilitating the proper handling and disposition of the recalled items. This proactive step by Bausch & Lomb was crucial for maintaining consumer trust and upholding regulatory integrity.