China NMPA Product Recall - Pre-loaded aspheric posterior chamber intraocular lens

The National Medical Products Administration (NMPA) has announced a voluntary Class II recall initiated by HOYA Medical Singapore Pte. Ltd. for its pre-loaded aspheric posterior chamber intraocular lenses. This action, reported by HOYA Medical (Ningbo) Medical Devices Co., Ltd., addresses a critical safety concern identified with the product's implantation mechanism. The main issue stems from the push-type implanter, which may rapidly release the intraocular lens, posing a significant risk of causing posterior capsule rupture during the implantation procedure. The affected product is identified under National Medical Device Registration Certificate No. 20163162624.

While the document does not detail specific inspection dates, the recall is a proactive measure taken by the manufacturer. The regulatory framework for this recall is established under the NMPA, which ensures medical device safety and compliance. HOYA Medical Singapore Pte. Ltd. is undertaking the required action of voluntarily recalling specific models, specifications, and batches of the implicated intraocular lenses. Further details regarding the affected products are contained within the "Medical Device Recall Event Report Form" associated with this announcement. This recall highlights the company's commitment to addressing product safety concerns promptly.