# China NMPA Product Recall - Soft contact lenses, 1-day ACUVUE TruEye Brand Contact Lenses with HYDRACLEAR 1 (narafilcon A)

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-vision-care-inc/3a13ed1a-8128-4db9-a555-c217c42389fd/
Source feed: China

> China NMPA product recall for Soft contact lenses, 1-day ACUVUE TruEye Brand Contact Lenses with HYDRACLEAR 1 (narafilcon A) by Johnson & Johnson Vision Care Inc. published January 10, 2020. Recall level: Level 3 Recall. Johnson & Johnson Vision Care Inc. initiated a voluntary Class III recall for its "Soft Contact Lens

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson Vision Care Inc. is voluntarily recalling its 1-day Acuvue TruEye brand soft contact lenses with Hydracare 1 (Narafilcon A).
- Company Name: Johnson & Johnson Vision Care Inc.
- Publication Date: 2020-01-10
- Product Name: Soft contact lenses, 1-day ACUVUE TruEye Brand Contact Lenses with HYDRACLEAR 1 (narafilcon A)
- Recall Level: Level 3 Recall
- Recall Reason: This involves the possibility of incorrect photometric markings on the product packaging.
- Discovering Company: Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Johnson & Johnson Vision Care Inc.
- Summary: Johnson & Johnson Vision Care Inc. initiated a voluntary Class III recall for its "Soft Contact Lenses 1 Day ACUVUE TruEye Brand Contact Lenses with HYDRACLEAR 1 (narafilcon A)." The recall, published on January 10, 2020, by Johnson & Johnson Vision Care Trading (Shanghai) Co., Ltd., addresses a potential error in the photometric labeling on the product packaging. This action was taken under the regulatory framework of the National Medical Products Administration (NMPA).

The main issue identified was a discrepancy in the photometric labeling applied to the packaging of the specified soft contact lenses. While specific inspection dates are not detailed in the document, the manufacturer proactively decided to recall affected batches due to this potential packaging error. The Class III classification indicates that the use of, or exposure to, the product is not likely to cause adverse health consequences.

The required action involves the comprehensive voluntary recall of all affected models, specifications, and batch information of the 1 Day ACUVUE TruEye Brand Contact Lenses with HYDRACLEAR 1. Further details on specific affected batches are contained within the accompanying "Medical Device Recall Event Report Form." This proactive measure by Johnson & Johnson Vision Care Inc. aims to ensure product quality and address any potential mislabeling concerns for consumers.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-vision-care-inc/97a98f3f-3fbb-40b6-8ba1-5a6e8537a514/