China NMPA Product Recall - Boston Simplus Multi-Action Solution for Rigid Corneal Contact Lens Care

Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its Boston Simplus Multi-Action Solution in China, impacting 11 specific batches manufactured at its Italian facility. This action, reported by the National Medical Products Administration (NMPA) on May 26, 2021, stems from an issue at a local plastic component sterilization supplier to Bausch & Lomb's Italian factory, where sterilization records for some plastic bottles, stoppers, and caps were found to be incomplete. Although Bausch & Lomb's internal production and testing confirmed that all manufactured care products adhered to processes and met quality requirements for sterility, ingredient content, and other physicochemical indicators (including safety and efficacy), the company decided to implement a precautionary recall. This decision reflects Bausch & Lomb's commitment to consumer health and safety, despite their own confirmed product quality. The recall requires the removal of the affected product batches from the market and is being conducted in China and other countries where the product was sold. Products manufactured at other Bausch & Lomb sites are not impacted by this recall.