China NMPA Product Recall - Hydrogen peroxide contact lens disinfectant (multipurpose solution)

CooperVision Manufacturing Ltd., in collaboration with CooperVision Optical Products Trading (Shanghai) Co., Ltd., has initiated a voluntary Class III recall of its Multipurpose Contact Lens Disinfectant Solution (Registration Certificate No.: 20173221843). This action, publicly reported by the National Medical Products Administration (NMPA) on December 30, 2021, addresses a critical product quality concern. The primary issue identified is the use of bottles manufactured from an unapproved grade of high-density polyethylene (HDPE) material, which was mistakenly supplied by a vendor. This material non-conformance deviates from the product's approved specifications. The recall specifically targets particular models, specifications, and batch numbers of the affected disinfectant solution, with comprehensive details available in the 'Medical Device Recall List' and an accompanying 'Medical Device Recall Event Report Form.' CooperVision's proactive measure aims to uphold product safety and ensure full compliance with the regulatory standards enforced by the NMPA, mitigating any potential risks associated with the unauthorized packaging material.