# China NMPA Product Recall - TECNIS® Toric 1-Piece IOL - One-Piece Multi-Surface Intraocular Lens

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-surgical-vision-inc/06eeeba9-0437-4820-bfc5-1d17ab388b64/
Source feed: China

> China NMPA product recall for TECNIS® Toric 1-Piece IOL - One-Piece Multi-Surface Intraocular Lens by Johnson Surgical Vision, Inc. published March 03, 2021. Recall level: Level 2. Johnson & Johnson Surgical Vision, Inc., in conjunction with its distributor Allergan (Shanghai) Med

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson Surgical Vision, Inc. is voluntarily recalling its TECNIS® Toric 1-Piece IOL.
- Company Name: Johnson Surgical Vision, Inc.
- Publication Date: 2021-03-03
- Product Name: TECNIS® Toric 1-Piece IOL - One-Piece Multi-Surface Intraocular Lens
- Recall Level: Level 2
- Recall Reason: The accidental release of substandard products of specific models or batches may lead to insufficient vision correction, thereby requiring secondary surgical intervention.
- Discovering Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Manufacturing Company: Johnson Surgical Vision, Inc.
- Summary: Johnson & Johnson Surgical Vision, Inc., in conjunction with its distributor Allergan (Shanghai) Medical Device Trading Co., Ltd., has initiated a voluntary Level II recall for specific models and batches of its TECNIS® Toric 1-Piece Intraocular Lens (IOL). This action, detailed in a National Medical Products Administration (NMPA) document published on March 3, 2021, addresses a critical quality issue. The recall stems from the accidental distribution of substandard products that may result in insufficient vision correction for patients. This deficiency could potentially necessitate a secondary surgical intervention, thereby posing risks to patient health and imposing additional burdens on healthcare providers. The company is undertaking this recall under the NMPA's regulatory framework to ensure product safety and maintain compliance with established quality standards. Comprehensive details concerning the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form," providing essential information for identifying and managing the recalled devices. This proactive measure underscores the company's commitment to addressing product deficiencies and protecting patient outcomes.

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