China NMPA Product Recall - Soft Hydrophilic Contact Lens

On December 23, 2024, CooperVision Inc., in conjunction with its reporting entity CooperVision Products Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall for its Soft Hydrophilic Contact Lenses. This significant action was taken due to the discovery of incorrect photometry affecting a small quantity of the manufactured lenses, indicating a deviation from established quality and performance specifications. The recall operates under the regulatory oversight of China's National Medical Products Administration (NMPA), which maintains stringent standards for medical device safety and market integrity. The primary issue identified, photometric inconsistency, is crucial for ensuring the optical precision and overall safety of the contact lenses. While a manufacturing defect was the catalyst for this recall, it is important to note that the specific products implicated were not imported into or distributed within the Chinese market. As a required action, CooperVision Inc. is proactively recalling these affected lenses globally to address the defect and mitigate any potential risks. The company has submitted a comprehensive 'Medical Device Recall Report Form,' detailing the specific models, specifications, and batch numbers involved, reaffirming its dedication to product quality and patient safety.