# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/colvision-medical-devices-shanghai-co-ltd/bcb247c2-8a99-47d6-8c88-e7c1c15af990/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by Colvision Medical Devices (Shanghai) Co., Ltd. published August 20, 2019. Recall level: Level 3 Recall. Colevision Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its s

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Colevision Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling soft hydrophilic contact lenses.
- Company Name: Colvision Medical Devices (Shanghai) Co., Ltd.
- Publication Date: 2019-08-20
- Product Name: Soft hydrophilic contact mirror
- Recall Level: Level 3 Recall
- Recall Reason: The products in question were found to have issues such as the absence of refractive index labels or markings on their packaging during national random inspections and tests.
- Discovering Company: Colvision Medical Devices (Shanghai) Co., Ltd.
- Manufacturing Company: Colvision Medical Devices (Shanghai) Co., Ltd.
- Summary: Colevision Medical Devices (Shanghai) Co., Ltd. has initiated a voluntary Class III recall for its soft hydrophilic contact lenses, as reported by the National Medical Products Administration (NMPA) on August 20, 2019. This significant action stems from findings during national random inspections, which revealed that a batch of these medical devices lacked essential refractive index labels or markings on their packaging. The absence of this critical information represents a violation of regulatory standards, potentially impacting user safety and product selection. The affected products were originally registered under Shanghai Food and Drug Administration Medical Device Registration Certificate No. 2019-206 and specifically apply to Certificate No.: 20143226232.

Under the regulatory oversight of the NMPA, Colevision Medical Devices is required to execute this recall to address the non-compliance. The company is mandated to provide comprehensive details concerning the model, specifications, and batch numbers of all impacted products through an official 'Medical Device Recall Event Report Form'. This voluntary recall demonstrates the company's commitment to rectifying the labeling deficiency and upholding the integrity and safety standards expected in the medical device industry, ensuring that all distributed products adhere to stipulated regulatory frameworks.

Company: https://www.globalkeysolutions.net/companies/colvision-medical-devices-shanghai-co-ltd/15b88173-f129-4778-8ad7-007fa3a2319a/