# China NMPA Product Recall - Intraocular lens implant

Source: https://www.globalkeysolutions.net/records/china_product_recall/bausch-lomb-shanghai-trading-co-ltd/c8e27ee1-f096-4dfe-b989-46688fe13a02
Source feed: China

> China NMPA product recall for Intraocular lens implant by Bausch & Lomb (Shanghai) Trading Co., Ltd. published June 19, 2017. Recall level: Level 2 Recall. Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its intraocular 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bausch & Lomb (Shanghai) Trading Co., Ltd. voluntarily recalls intraocular lens implants.
- Company Name: Bausch & Lomb (Shanghai) Trading Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Intraocular lens implant
- Recall Level: Level 2 Recall
- Recall Reason: The product may contain burrs, which could cause distortion of the crystal leader loop.
- Discovering Company: Bausch & Lomb (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Bausch & Lomb (Shanghai) Trading Co., Ltd.
- Summary: Bausch & Lomb (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its intraocular lens implants (IOLs), as announced by the National Medical Products Administration (NMPA) on June 19, 2017. This regulatory action pertains to IOLs registered under National Medical Device Registration Certificate No. 20142045599. While the specific reasons prompting the recall are not detailed in this public notice, a voluntary recall at Class II level typically signifies a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company proactively removed the affected medical devices from the market to ensure patient safety and maintain product integrity. Full particulars concerning the models, specifications, and batch numbers of the implicated products are contained within the 'Medical Device Recall Event Report Form,' which accompanies the official NMPA announcement. This recall underscores the rigorous regulatory oversight exercised by the NMPA over medical devices in China, ensuring that companies adhere to strict quality and safety standards for products available to the public. Bausch & Lomb's voluntary action reflects its commitment to compliance with national medical device regulations and patient well-being, under the framework of NMPA's comprehensive supervision.

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-shanghai-trading-co-ltd/de0f5987-0863-4143-9fc4-9dd418073f35