# China NMPA Product Recall - Viscoelastic agents for ophthalmic surgery (Amvisc, Amvisc Plus)

Source: https://www.globalkeysolutions.net/records/china_product_recall/bausch-lomb-inc/528d31fe-6407-4e85-a1b8-d9cfa7e7b587/
Source feed: China

> China NMPA product recall for Viscoelastic agents for ophthalmic surgery (Amvisc, Amvisc Plus) by Bausch & Lomb Inc. published March 26, 2013. Recall level: . Bausch & Lomb Inc., operating through Bausch & Lomb (Shanghai) Trading Co., Ltd., initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Bausch & Lomb Inc. recalls viscoelastic agents used in ophthalmic surgery.
- Company Name: Bausch & Lomb Inc.
- Publication Date: 2013-03-26
- Product Name: Viscoelastic agents for ophthalmic surgery (Amvisc, Amvisc Plus)
- Recall Reason: Bausch & Lomb recently discovered that some 27G disposable needles supplied with Amvisc or Amvisc Plus ophthalmic surgical viscoelastics do not properly engage with the Luer connector of the Amvisc or Amvisc Plus sterile glass syringe. During injection, the 27G disposable needle may leak viscoelastic material or detach from the syringe. In rare cases, detachment can cause serious harm to the patient.
- Discovering Company: Bausch & Lomb (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Bausch & Lomb Inc.
- Summary: Bausch & Lomb Inc., operating through Bausch & Lomb (Shanghai) Trading Co., Ltd., initiated a voluntary recall of specific batches of its ophthalmic surgical viscoelastic agents, Amvisc and Amvisc Plus. This recall, detailed in a National Medical Products Administration (NMPA) document published on March 26, 2013, addressed a critical defect where 27G disposable needles supplied with the products improperly engaged with the sterile glass syringe's Luer connector. This issue could lead to the leakage of viscoelastic material or, more seriously, needle detachment during surgery, posing a risk of severe patient harm.

The company commenced recall activities in late 2012, receiving notification from its U.S. headquarters on November 15. By November 22, affected batch numbers, including D110092A, D110071A, B120016A, and B110048A, were confirmed. Immediately, Bausch & Lomb notified all distributors in China to halt sales and retrieve products from hospital distribution channels. By December 10, 2012, all 151 affected viscoelastic products in China were successfully returned. The company committed to disposing of these products by the end of December 2012 in accordance with national regulations, aiming to complete the entire recall by that time, under the oversight implied by the product's CFDA Import Registration Certificate No. 20103221132.

Company: https://www.globalkeysolutions.net/companies/bausch-lomb-inc/4b07b83b-4c0c-4932-9017-8e0c63105b7e/