China NMPA Product Recall - Multi-purpose contact lens solution

On December 30, 2021, CooperVision Manufacturing Ltd., through its subsidiary CooperVision Products Trading (Shanghai) Co., Ltd., initiated a voluntary Class III recall of its Multi-purpose Contact Lens Solution. The decision was prompted by the use of bottles manufactured from an unapproved grade of high-density polyethylene (HDPE) material. This material was mistakenly supplied by a third-party vendor, leading to a deviation from approved specifications for the product’s packaging. The National Medical Products Administration (NMPA) oversaw this recall action, documented under Index No. JGXX-2021-10739. The recall specifically targets certain models, specifications, and batches of the contact lens solution, as detailed in the "Medical Device Recall Event Report Form" associated with Registration Certificate No.: 20173221843. CooperVision's proactive measure underscores its commitment to product safety and compliance with regulatory standards. The company is required to identify and remove all affected products from distribution to safeguard consumer health. This recall ensures that products reaching consumers adhere strictly to established material and quality control guidelines.