# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/coopervision-inc/21fed279-4107-42c5-a7b9-24aae2e28478/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by CooperVision Inc. published July 26, 2023. Recall level: . CooperVision Inc., through its subsidiary CooperVision Products Trading (Shanghai) Co., Ltd., initia

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: CooperVision Inc. is voluntarily recalling soft hydrophilic contact lenses.
- Company Name: CooperVision Inc.
- Publication Date: 2023-07-26
- Product Name: Soft hydrophilic contact mirror
- Recall Reason: Tag template mismatch
- Discovering Company: CooperVision Products Trading (Shanghai) Co., Ltd.
- Manufacturing Company: CooperVision Inc.
- Summary: CooperVision Inc., through its subsidiary CooperVision Products Trading (Shanghai) Co., Ltd., initiated a voluntary recall of specific soft hydrophilic contact lenses. This action was publicly announced by the National Medical Products Administration (NMPA) on July 26, 2023. The primary issue prompting the recall was a detected label template mismatch on the affected products. These lenses are registered under National Medical Device Registration Certificate No. 20163162038, indicating their authorization within the Chinese regulatory framework. Although specific inspection dates are not detailed in the public notification, the company voluntarily reported the labeling discrepancy to the NMPA. The required action involves retrieving all impacted products from the market to address this compliance deviation. Comprehensive details, including the models, specifications, and batch numbers of the affected lenses, are documented in a "Medical Device Recall Event Report Form" submitted by CooperVision Products Trading (Shanghai) Co., Ltd. This voluntary recall highlights the company's commitment to product integrity and adherence to NMPA regulations regarding medical device labeling standards.

Company: https://www.globalkeysolutions.net/companies/coopervision-inc/ab8eedee-5dce-4363-b41f-8184836e301d/