China NMPA Product Recall - Pre-loaded intraocular lens

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.