# China NMPA Product Recall - Aspheric posterior chamber intraocular lens (trade name: HOYA AF-1 iMics1); Pre-loaded aspheric posterior chamber intraocular lens (trade name: HOYA iSert)

Source: https://www.globalkeysolutions.net/records/china_product_recall/hoya-corporation/66e06bd4-f55e-4b88-84b4-ea10a31da759/
Source feed: China

> China NMPA product recall for Aspheric posterior chamber intraocular lens (trade name: HOYA AF-1 iMics1); Pre-loaded aspheric posterior chamber intraocular lens (trade name: HOYA iSert) by HOYA CORPORATION published June 17, 2013. Recall level: . HOYA CORPORATION initiated a voluntary global recall of its Aspheric Posterior Chamber Intraocular L

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: HOYA CORPORATION has recalled aspheric posterior chamber intraocular lenses and pre-loaded aspheric posterior chamber intraocular lenses.
- Company Name: HOYA CORPORATION
- Publication Date: 2013-06-17
- Product Name: Aspheric posterior chamber intraocular lens (trade name: HOYA AF-1 iMics1); Pre-loaded aspheric posterior chamber intraocular lens (trade name: HOYA iSert)
- Recall Reason: Physicians in some countries using NY-60, iSert 250, and iSert 251 IOLs have reported higher-than-expected rates of inflammation and/or intraocular involvement.
- Discovering Company: Shenzhen Ruilin Medical Devices Co., Ltd.
- Manufacturing Company: HOYA CORPORATION
- Summary: HOYA CORPORATION initiated a voluntary global recall of its Aspheric Posterior Chamber Intraocular Lenses (HOYA AF-1 iMics1) and Pre-loaded Aspheric Posterior Chamber Intraocular Lenses (HOYA iSert) in May 2013, as reported to the National Medical Products Administration (NMPA), then known as CFDA. This action followed reports from doctors indicating a higher-than-expected incidence of inflammation and/or intraocular involvement in patients using these devices. No specific inspection dates were provided, as this was a company-initiated recall rather than an NMPA enforcement action. The affected products, registered under CFDA (Imported) No. 20103223383 and No. 3224320, included models NY-60 and 251, with significant quantities distributed in China. Under the NMPA's regulatory framework, HOYA CORPORATION's responsible unit in China swiftly enacted corrective measures. These included freezing all affected inventory, notifying customers of the recall, and arranging for the return of all unused products to the Singapore manufacturing facility warehouse. Additionally, provincial and local food and drug administrations were instructed to strengthen their supervision over similar products to ensure ongoing patient safety and product quality.

Company: https://www.globalkeysolutions.net/companies/hoya-corporation/879a88c5-84cb-4b2a-9001-30922ec9a316/