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

Source: https://www.globalkeysolutions.net/records/china_product_recall/hoya-corporation/203f8b65-f124-48e1-b7bb-754c7790f2b6/
Source feed: China

> China NMPA product recall for Aspheric posterior chamber intraocular lens (trade name: HOYA AF-1 iMicsl); Pre-loaded aspheric posterior chamber intraocular lens (trade name: HOYA iSert) by HOYA CORPORATION published April 19, 2013. Recall level: . The National Medical Products Administration (NMPA) announced a voluntary recall on April 19, 2013, 

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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: 2013-04-19
- Product Name: Aspheric posterior chamber intraocular lens (trade name: HOYA AF-1 iMicsl); 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 a higher-than-expected incidence of inflammation and/or endophthalmitis.
- Discovering Company: Shenzhen Ruilin Medical Devices Co., Ltd.
- Manufacturing Company: HOYA CORPORATION
- Summary: The National Medical Products Administration (NMPA) announced a voluntary recall on April 19, 2013, initiated by HOYA CORPORATION. The recall involves their aspheric posterior chamber intraocular lenses (HOYA AF-1 iMicsl, models NY-60 and 251) and pre-loaded aspheric posterior chamber intraocular lenses (HOYA iSert). This action was taken due to a higher-than-expected incidence of inflammation or endophthalmitis reported by medical professionals using these devices. Shenzhen Ruilin Medical Devices Co., Ltd., HOYA's responsible unit in China, reported the issue. Under the NMPA's regulatory oversight, provincial food and drug administrations were directed to strengthen supervision of similar products. Required actions included immediately freezing affected product inventory by distributors, notifying customers of corrective measures, recalling all unused affected products, and returning them to the manufacturing facility in Singapore to ensure patient safety.

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