# China NMPA Product Recall - Soft hydrophilic contact lens (brand name: Colorful)

Source: https://www.globalkeysolutions.net/records/china_product_recall/bausch-lomb-eye-care-products-co-ltd/2c2ab2ea-5e8c-4b4a-8c3b-98a9deb04af5
Source feed: China

> China NMPA product recall for Soft hydrophilic contact lens (brand name: Colorful) by Bausch & Lomb Eye Care Products Co., Ltd. published February 23, 2016. Recall level: Level 3 Recall. Bausch & Lomb Beijing Eye Care Products Co., Ltd. initiated a voluntary Class III recall of its "Col

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bausch & Lomb Beijing Eye Care Products Co., Ltd. is voluntarily recalling its soft hydrophilic contact lenses (trade name: Colorful).
- Company Name: Bausch & Lomb Eye Care Products Co., Ltd.
- Publication Date: 2016-02-23
- Product Name: Soft hydrophilic contact lens (brand name: Colorful)
- Recall Level: Level 3 Recall
- Recall Reason: The refractive index of this batch of products was measured at 1.444, exceeding the upper limit requirement of the nominal value of 1.437 ± 0.005.
- Discovering Company: Bausch & Lomb Eye Care Products Co., Ltd.
- Manufacturing Company: Bausch & Lomb Eye Care Products Co., Ltd.
- Summary: Bausch & Lomb Beijing Eye Care Products Co., Ltd. initiated a voluntary Class III recall of its "Colorful" brand Soft Hydrophilic Contact Lenses (CFDA Registration No. 20133221188). This action, publicized on February 23, 2016, followed findings from the National Medical Device Quality Bulletin dated December 22, 2015. The primary issue identified was a non-conformity in a specific product batch (B41001502, Posterior Vertex Power -1.00D). Testing revealed the refractive index to be 1.444, which exceeded the specified upper limit of 1.437 	0.005. Despite this deviation, a company risk assessment concluded that the probability of harm to users was very low. Operating under the oversight of the National Medical Products Administration (NMPA), Bausch & Lomb proactively implemented the recall. The required actions included summarizing production, sales, and inventory data for the affected batch, as well as engaging distributors to manage existing stock. A total of 377 units were produced, with 322 units sold in China. This recall underscores the company's commitment to product quality and compliance with national medical device standards, even when potential risks are deemed minimal.

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-eye-care-products-co-ltd/41c8e2a6-7667-4514-bc55-c97e617bc36d