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

Source: https://www.globalkeysolutions.net/records/china_product_recall/oculentis-bv/463e3cec-43f5-4415-8ad1-4cde606d8ca5/
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., an intraocular lens manufacturer, initiated a Class III voluntary recall of its asph

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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: Oculentis received notification that a small number of patients experienced intraocular lens (IOL) clouding in the later stages of surgery, which could affect the optical transparency of the IOL and lead to a slow decline in the patient's vision. According to relevant literature, clouding can be caused by a variety of reasons. Oculentis investigated the possible causes of clouding in its products and decided to proactively recall the affected products to prevent any risks to patients.
- Discovering Company: Beijing High Vision Vision Technology Co., Ltd.
- Manufacturing Company: Oculentis B.V.
- Summary: Oculentis B.V., an intraocular lens manufacturer, initiated a Class III voluntary recall of its aspheric and spherical intraocular lenses, including models L-312, L-313, and PCA81, with expiration dates spanning January 2017 to May 2020. This recall, reported to the National Medical Products Administration (NMPA) on September 27, 2017, and published on October 10, 2017, was prompted by patient reports of intraocular lens opacity occurring in the later postoperative period. This issue potentially affects the optical transparency of the lenses, leading to a gradual decline in vision. The recall affects approximately 520,000 units globally, with 54,858 products sold in China. Beijing Gaoshi Yuanwang Technology Co., Ltd. is the agent managing the recall within China. Corrective actions include immediately stopping sales and use of unimplanted stock, recalling all affected products, and providing free replacements with new products. Affected batches will be destroyed. For patients with implanted lenses that develop significant clouding affecting vision, Oculentis B.V. committed to providing necessary assistance, including free replacements if IOL replacement surgery is required. This measure was taken proactively to mitigate potential patient risks.

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