China NMPA Product Recall - Soft hydrophilic contact lens
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The National Medical Products Administration (NMPA) announced on September 5, 2025, a voluntary Class III recall by CooperVision Inc. concerning specific batches of its soft hydrophilic contact lenses. CooperVision Products Trading (Shanghai) Co., Ltd. facilitated the reporting of this action within China. The recall stems from a potential risk of incomplete sterilization in certain product batches, which could affect product safety and integrity. This action falls under the regulatory purview of the NMPA, referencing the product's National Medical Device Registration Certificate No. 20213160048. A critical aspect of this recall is that the involved products were not imported into the Chinese market. Consequently, Chinese consumers are not directly affected by these specific recalled batches. The required action by the company is the voluntary withdrawal of the affected products from the market. Comprehensive details, including specific models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" referenced in the NMPA's official announcement.
- Company
- CooperVision Inc.
ID · eb59cc86-59d5-4849-ba1b-59e8ef6934bd