# China NMPA Product Recall - Soft hydrophilic contact mirror

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-weikang-optical-glasses-co-ltd/ede44d04-ee35-44e2-8e54-a0d94c672101/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact mirror by Shanghai Weikang Optical Glasses Co., Ltd. published December 07, 2016. Recall level: . Shanghai Weikang Optical Glasses Co., Ltd. initiated a voluntary recall of specific batches of its S

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Weikang Optical Glasses Co., Ltd. is voluntarily recalling soft hydrophilic contact lenses.
- Company Name: Shanghai Weikang Optical Glasses Co., Ltd.
- Publication Date: 2016-12-07
- Product Name: Soft hydrophilic contact mirror
- Recall Reason: On September 19, 2016, we received a "Notification of Delivery of Inspection Results for National Medical Device Sampling Inspection Products" from the Pudong New Area Market Supervision and Administration Bureau of Shanghai. The product failed the "total diameter" test and therefore needs to be recalled.
- Discovering Company: Shanghai Weikang Optical Glasses Co., Ltd.
- Manufacturing Company: Shanghai Weikang Optical Glasses Co., Ltd.
- Summary: Shanghai Weikang Optical Glasses Co., Ltd. initiated a voluntary recall of specific batches of its Soft Hydrophilic Contact Lenses in response to findings from a national medical device sampling inspection. On September 19, 2016, the company received notification that the "total diameter" of certain contact lens products was unqualified. The affected products include models such as Butterfly Color, Candy Honey Love, and Brown, across batches NZ007G07, NZ011G06, and NZ007G14, with 1644 lenses sold in Mainland China requiring recall. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA)'s framework for medical device quality. As part of the corrective measures, Shanghai Weikang Optical Glasses Co., Ltd. committed to notifying distributors and sales staff to retrieve the substandard products and indicated that further processing would be undertaken by OPTIC to address the issue. The company formally reported the recall on September 22, 2016.

Company: https://www.globalkeysolutions.net/companies/shanghai-weikang-optical-glasses-co-ltd/21f83881-796b-4aef-95d4-ab4f8da47a16/