# China NMPA Product Recall - Glass cutter

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-medical-optics-inc/68c8b842-5410-401f-9304-2ecdf6a97ec1/
Source feed: China

> China NMPA product recall for Glass cutter by Abbott Medical Optics Inc. published May 17, 2017. Recall level: . The National Medical Products Administration (NMPA) issued a notice concerning a voluntary product r

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical Optics Inc. recalls vitrectomy blades.
- Company Name: Abbott Medical Optics Inc.
- Publication Date: 2017-05-17
- Product Name: Glass cutter
- Recall Reason: This recall is being initiated due to a possible packaging error, specifically that products in the packaging of a 20GA glass cutter and a 25GA glass cutter may have been mixed up.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Abbott Medical Optics Inc.
- Summary: The National Medical Products Administration (NMPA) issued a notice concerning a voluntary product recall initiated by Abbott Medical Optics Inc. The recall, reported on April 21, 2017, pertains to specific vitrectomy blades distributed in China by Allergan (Shanghai) Medical Device Trading Co., Ltd. The main issue identified was a potential packaging error, where 20GA and 25GA glass cutters, critical components of ophthalmic phacoemulsification devices, may have been inadvertently mixed. These blades are single-use tools for removing vitreous humor and are intended for use with the AMO WHITESTAR SIGNATURE system. The product is regulated under CFDA (Imported) Registration Certificate No. 20133234023. Abbott Medical Optics Inc. confirmed that the affected batches were not sold or imported into China. Therefore, no direct corrective actions are required within China concerning the recalled products. However, the NMPA requested all provincial Food and Drug Administrations to strengthen their oversight and management of similar medical devices to ensure public safety.

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