# China NMPA Product Recall - Pre-loaded intraocular lens

Source: https://www.globalkeysolutions.net/records/china_product_recall/hoya-medical-singapore-pte-ltd/8182974c-285f-48bc-9c56-2090670daaaf
Source feed: China

> China NMPA product recall for Pre-loaded intraocular lens by HOYA Medical Singapore Pte. Ltd published August 29, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on August 29, 2023, that HOYA Medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: HOYA Medical Singapore Pte. Ltd. is voluntarily recalling pre-loaded intraocular lenses.
- Company Name: HOYA Medical Singapore Pte. Ltd
- Publication Date: 2023-08-29
- Product Name: Pre-loaded intraocular lens
- Recall Level: Level 2 Recall
- Recall Reason: Because the intraocular lens is implanted using a push-and-drop method, the implanter may rapidly release the lens, potentially leading to posterior capsule rupture in some cases.
- Discovering Company: Haoya (Shenzhen) Medical Device Consulting Co., Ltd.
- Manufacturing Company: HOYA Medical Singapore Pte. Ltd
- Summary: The National Medical Products Administration (NMPA) announced on August 29, 2023, that HOYA Medical Singapore Pte. Ltd. is initiating a voluntary Class II recall of its pre-loaded intraocular lenses (National Medical Device Registration No. 20233160098). The decision stems from an identified issue where the push-type implantation mechanism of the intraocular lens delivery system may cause the lens to be released too rapidly. This accelerated release poses a risk of posterior capsule rupture in some patients during the surgical procedure. HOYA (Shenzhen) Medical Device Consulting Co., Ltd. reported this potential safety concern, prompting the manufacturer, HOYA Medical Singapore Pte. Ltd., to take corrective action. The recall specifically targets affected product models, specifications, and batches, details of which are provided in an attached Medical Device Recall Event Report Form. This action underscores the NMPA's regulatory oversight in ensuring the safety and efficacy of medical devices circulating within its jurisdiction. Manufacturers are responsible for promptly addressing product deficiencies that could compromise patient safety, as demonstrated by this voluntary recall.

Company: https://www.globalkeysolutions.net/companies/hoya-medical-singapore-pte-ltd/1cc42b27-f916-4faf-9c27-45e4abb0e0d1