# China NMPA Product Recall - WHITESTAR Signature Phacoemulsification System

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-surgical-vision-inc/3d218174-f6ea-4a05-a888-5b754731ea59/
Source feed: China

> China NMPA product recall for WHITESTAR Signature Phacoemulsification System by Johnson Surgical Vision, Inc. published September 18, 2021. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a recall notice on September 18, 2021,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson Surgical Vision, Inc. is voluntarily recalling its Whitestar Signature Phacoemulsification System.
- Company Name: Johnson Surgical Vision, Inc.
- Publication Date: 2021-09-18
- Product Name: WHITESTAR Signature Phacoemulsification System
- Recall Level: Level 3 Recall
- Recall Reason: A minor raw material design change submitted to the Japanese PMDA in February 2017 was not approved.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Johnson Surgical Vision, Inc.
- Summary: The National Medical Products Administration (NMPA) published a recall notice on September 18, 2021, concerning a voluntary Class III recall initiated by Johnson & Johnson Surgical Vision, Inc. This recall, issued through Allergan (Shanghai) Medical Devices Trading Co., Ltd., pertains to specific models and batches of the WHITESTAR Signature Phacoemulsification System. The core issue stems from an unapproved minor raw material design change that was submitted to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in February 2017. Despite the lack of regulatory approval from the PMDA for this modification, products incorporating the change appear to have entered distribution. As a result, Johnson & Johnson Surgical Vision, Inc. is now voluntarily recalling these affected medical devices to ensure compliance with regulatory standards. This action underscores the necessity of securing all required regulatory clearances for any design alterations to medical products before manufacturing or distribution. Further detailed information, including specific models, specifications, and batch numbers of the affected products, is available in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/johnson-surgical-vision-inc/e91c237d-79c4-451e-829a-5d15e4035e19/