# China NMPA Product Recall - Aspheric intraocular lens, aspheric intraocular lens, spherical intraocular lens

Source: https://www.globalkeysolutions.net/records/china_product_recall/oculentis-bv/9de8830e-7239-478d-a458-6a885a912db9/
Source feed: China

> China NMPA product recall for Aspheric intraocular lens, aspheric intraocular lens, spherical intraocular lens by Oculentis B.V. published October 10, 2017. Recall level: Level 3 Recall. Oculentis B.V., a manufacturer of intraocular lenses (IOLs), initiated a voluntary Class III recall 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Oculentis B.V. is actively recalling aspheric intraocular lenses (IOLs).
- Company Name: Oculentis B.V.
- Publication Date: 2017-10-10
- Product Name: Aspheric intraocular lens, aspheric intraocular lens, spherical intraocular lens
- Recall Level: Level 3 Recall
- Recall Reason: In rare cases, patients experience intraocular lens opacity in the later stages of surgery, which may affect the optical transparency of the intraocular lens and lead to a gradual decline in the patient's vision.
- Discovering Company: Beijing High Vision Vision Technology Co., Ltd.
- Manufacturing Company: Oculentis B.V.
- Summary: Oculentis B.V., a manufacturer of intraocular lenses (IOLs), initiated a voluntary Class III recall of its aspheric and spherical IOLs, as reported by the National Medical Products Administration (NMPA) on October 10, 2017. The recall, submitted by agent Beijing Gaoshi Yuanwang Technology Co., Ltd. on September 27, 2017, addresses patient reports of IOL opacity occurring in the later postoperative period. This issue impacts the optical clarity of the lenses, potentially leading to a gradual decline in vision. Affected products include models L-312, L-313, and PCA81, with expiration dates ranging from January 2017 to May 2020, impacting over 54,000 units sold in China. Under NMPA's regulatory framework for medical devices, Oculentis B.V. proactively investigated the cause of the clouding and implemented corrective actions. These include instructing all distributors to immediately cease sales and use of remaining stock and to recall any unimplanted lenses. The company committed to providing equivalent new products free of charge as replacements for recalled items, which will subsequently be destroyed. For patients who have already received the affected IOLs and experience significant vision impairment due to clouding, Oculentis B.V. will offer necessary assistance and provide free replacement lenses, potentially necessitating IOL replacement surgery.

Company: https://www.globalkeysolutions.net/companies/oculentis-bv/9ab1a9c6-ab15-4436-9d10-6ca314c12a0c/