# China NMPA Product Recall - Polyacrylate posterior chamber intraocular lenses (trade name: Sensar), foldable posterior chamber acrylic intraocular lenses (trade name: Tecnis)

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-optics-inc/cbb5358e-bff0-4d82-b672-31bc5c3ce0b4/
Source feed: China

> China NMPA product recall for Polyacrylate posterior chamber intraocular lenses (trade name: Sensar), foldable posterior chamber acrylic intraocular lenses (trade name: Tecnis) by Abbott Medical Optics Inc. published December 07, 2016. Recall level: Level II. Allergan (Shanghai) Medical Devices Trading Co., Ltd., the China-based responsible unit for products

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Allergan (Shanghai) Medical Devices Trading Co., Ltd. is voluntarily recalling polyacrylate posterior chamber intraocular lenses and foldable posterior chamber acrylic intraocular lenses.
- Company Name: Abbott Medical Optics Inc.
- Publication Date: 2016-12-07
- Product Name: Polyacrylate posterior chamber intraocular lenses (trade name: Sensar), foldable posterior chamber acrylic intraocular lenses (trade name: Tecnis)
- Recall Level: Level II
- Recall Reason: Our company is voluntarily recalling a certain number of Sensar and Tecnis intraocular lenses due to a malfunction in one of our testing devices. This malfunction resulted in some lenses not undergoing all required checks before release. This malfunction may have led to the release of lenses with incorrect labels. Using incorrectly labeled lenses could potentially cause unintended postoperative refractive errors, which may require a second surgical intervention for correction.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Abbott Medical Optics Inc.
- Summary: Allergan (Shanghai) Medical Devices Trading Co., Ltd., the China-based responsible unit for products manufactured by Abbott Medical Optics Inc., initiated a Class II voluntary recall of specific intraocular lenses (IOLs), including Sensar AR40e and Tecnis ZCB00 models. This recall, reported to the National Medical Products Administration (NMPA) on September 5, 2016, and publicly announced on December 7, 2016, was prompted by the discovery of a malfunction in a testing device. This malfunction resulted in certain IOLs not undergoing all required quality checks before release, potentially leading to incorrect product labeling. The primary concern is that using an incorrectly labeled IOL could cause unintended postoperative refractive errors in adult patients, potentially necessitating further surgical intervention. Under the NMPA's regulatory framework, Allergan Shanghai directed all distributors to contact customers, stop shipments and use of any remaining unimplanted stock, and facilitate the return of these affected lenses. IOLs already implanted and functioning effectively are not impacted by this recall action.

Company: https://www.globalkeysolutions.net/companies/abbott-medical-optics-inc/880596cf-ac9e-4b01-bce5-e1a8dab0e081/