# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/qingdao-newbayo-optical-manufacturing-co-ltd/e1e874c5-804b-4728-ae48-5e40ad439e19/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by Qingdao Newbayo Optical Manufacturing Co., Ltd. published December 06, 2018. Recall level: Level 3 Recall. Qingdao Newbay Optical Manufacturing Co., Ltd. has initiated a voluntary Level III recall of its sof

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Qingdao Newbayo Optical Manufacturing Co., Ltd. has voluntarily recalled its soft hydrophilic contact lenses (production batch numbers 20180720 and 20180719).
- Company Name: Qingdao Newbayo Optical Manufacturing Co., Ltd.
- Publication Date: 2018-12-06
- Product Name: Soft hydrophilic contact mirror
- Recall Level: Level 3 Recall
- Recall Reason: The test for sterile osmotic pressure is missing.
- Discovering Company: Qingdao Newbayo Optical Manufacturing Co., Ltd.
- Manufacturing Company: Qingdao Newbayo Optical Manufacturing Co., Ltd.
- Summary: Qingdao Newbay Optical Manufacturing Co., Ltd. has initiated a voluntary Level III recall of its soft hydrophilic contact lenses, specifically targeting production batch numbers 20180720 and 20180719. This recall, publicly reported on December 6, 2018, was prompted by findings from national unannounced inspections conducted by the National Medical Products Administration (NMPA). The core issue identified was a critical omission in the test reports for the affected batches: a lack of required sterility osmotic pressure testing items. This deficiency indicated a lapse in quality control processes, which are crucial for ensuring the safety and performance of medical devices like contact lenses. In response to these regulatory findings, Qingdao Newbay Optical Manufacturing Co., Ltd. is implementing recall measures to retrieve the non-compliant products from the market. This action aligns with the NMPA's regulatory framework for medical device oversight, emphasizing the company's responsibility to adhere to comprehensive testing protocols. Further specifics regarding the recalled product models and specifications are detailed in the official "Medical Device Recall Event Report Form," ensuring transparency in addressing this quality concern.

Company: https://www.globalkeysolutions.net/companies/qingdao-newbayo-optical-manufacturing-co-ltd/ebd70c65-07a4-4231-a0c4-ade98f4a30cc/