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)

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.