# China NMPA Product Recall - Polyacrylate posterior chamber intraocular lenses; Foldable posterior chamber acrylic intraocular lenses

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-optics-inc/401321f9-16ad-4164-ba22-74804b320aed/
Source feed: China

> China NMPA product recall for Polyacrylate posterior chamber intraocular lenses; Foldable posterior chamber acrylic intraocular lenses by Abbott Medical Optics Inc. published December 07, 2016. Recall level: Level II. Allergan (Shanghai) Medical Devices Trading Co., Ltd. initiated a voluntary Class II recall, announc

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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; Foldable posterior chamber acrylic intraocular lenses
- Recall Level: Level II
- Recall Reason: A malfunction in the testing equipment was discovered, resulting in some intraocular lenses (IOLs) not undergoing all required checks before release. This malfunction may have led to the release of IOLs with incorrect labels. Using incorrectly labeled IOLs 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. initiated a voluntary Class II recall, announced on December 7, 2016, for specific batches of Polyacrylate Posterior Chamber Intraocular Lenses (Sensar) and Foldable Posterior Chamber Acrylic Intraocular Lenses (Tecnis). The recall stemmed from a malfunction in a testing device, which led to some lenses not undergoing all required pre-release checks. This defect could result in incorrectly labeled products. The use of improperly labeled intraocular lenses carries the risk of unintended postoperative refractive errors for patients who have undergone cataract extraction surgery, potentially necessitating further surgical intervention. The regulatory oversight for this recall falls under the National Medical Products Administration (NMPA) of China. Abbott Medical Optics Inc. is identified as the manufacturer. As part of the required actions, Allergan (Shanghai) Medical Devices Trading Co., Ltd. has instructed distributors to cease shipments and use of any unimplanted affected lenses. Customers holding unimplanted lenses are required to return them. Importantly, intraocular lenses already implanted and performing well are not subject to this recall, aiming to prevent unnecessary patient procedures while addressing the risk posed by mislabeled devices.

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