# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/coopervision-inc/34f35314-6f59-4b31-a38d-4f752c87e121/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by CooperVision Inc. published March 03, 2021. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) of China announced on March 3, 2021, a Class III

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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: 2021-03-03
- Product Name: Soft hydrophilic contact mirror
- Recall Level: Level 3 Recall
- Recall Reason: Foreign objects were found in the packaging of specific models and batches of products.
- Discovering Company: CooperVision Products Trading (Shanghai) Co., Ltd.
- Manufacturing Company: CooperVision Inc.
- Summary: The National Medical Products Administration (NMPA) of China announced on March 3, 2021, a Class III voluntary recall initiated by CooperVision Inc. concerning specific models and batches of its soft hydrophilic contact lenses. The recall was reported by CooperVision Products Trading (Shanghai) Co., Ltd., the manufacturer's local entity, to the NMPA.

The primary issue identified leading to this action is the confirmed presence of foreign objects found within the packaging of the affected contact lens products. Such contamination could potentially compromise product sterility or cause discomfort and injury to users, underscoring the critical need for product integrity in medical devices.

Operating under the oversight of the NMPA, the recalled products are registered under National Medical Device Registration Certificate No. 20153162423. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. However, CooperVision Inc. is proactively recalling these products to uphold its commitment to patient safety and adherence to rigorous quality standards.

The required action involves the manufacturer's voluntary removal of the impacted contact lenses from the market. Comprehensive details, including the specific models, specifications, and batch numbers of the affected products, are documented in the official 'Medical Device Recall Event Report Form' made available by the NMPA. This incident highlights the importance of stringent quality control throughout the manufacturing and packaging processes of medical devices to ensure public health and safety.

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