# China NMPA Product Recall - Soft hydrophilic contact lens, 42% hioxifilcon A, 58% water content (spherical), daily disposable.

Source: https://www.globalkeysolutions.net/records/china_product_recall/koribo-shanghai-eyewear-co-ltd/5be30813-fb8a-4cb0-ac9f-357c6597bec7/
Source feed: China

> China NMPA product recall for Soft hydrophilic contact lens, 42% hioxifilcon A, 58% water content (spherical), daily disposable. by Koribo (Shanghai) Eyewear Co., Ltd. published June 25, 2021. Recall level: Level 3 Recall. Kelibo (Shanghai) Optical Co., Ltd. initiated a voluntary Class III recall for its soft hydrophilic 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kolibo (Shanghai) Optical Co., Ltd. is voluntarily recalling its soft hydrophilic contact lenses containing 42% hioxifilcon A and 58% water content (spherical) for daily disposable use.
- Company Name: Koribo (Shanghai) Eyewear Co., Ltd.
- Publication Date: 2021-06-25
- Product Name: Soft hydrophilic contact lens, 42% hioxifilcon A, 58% water content (spherical), daily disposable.
- Recall Level: Level 3 Recall
- Recall Reason: Minimum sterile packaging labeling non-compliant
- Discovering Company: Koribo (Shanghai) Eyewear Co., Ltd.
- Manufacturing Company: Koribo (Shanghai) Eyewear Co., Ltd.
- Summary: Kelibo (Shanghai) Optical Co., Ltd. initiated a voluntary Class III recall for its soft hydrophilic contact lenses, specifically the 42% hioxifilcon A, 58% water content (spherical) daily disposable variant. This action was reported on June 25, 2021, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The primary reason for the recall was identified as non-compliance with minimum sterile packaging labeling requirements, a critical issue for medical devices that could affect product identification and safe use. Such labeling deficiencies necessitate corrective action to uphold patient safety and regulatory standards. The recall impacts specific models, specifications, and batches, with detailed information available in an accompanying Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's commitment to addressing product deficiencies in adherence to China's stringent medical product regulatory framework, ensuring the integrity and safety of medical devices in the market.

Company: https://www.globalkeysolutions.net/companies/koribo-shanghai-eyewear-co-ltd/09a894bf-510f-4bb2-b9a5-9eb16fd0b77a/