China NMPA Product Recall - Z-Hyalin Plus Hyaluronic Acid Solution for use in intraocular surgery

The National Medical Products Administration (NMPA) announced on October 18, 2024, a voluntary Class II recall initiated by Hyaltech Ltd. The recall specifically concerns their 'Z-Hyalin Plus Vis solution for use in intraocular surgery' (National Medical Device Registration Certificate 20193162441). Carl Zeiss (Shanghai) Management Co., Ltd. reported this action on behalf of Hyaltech Ltd. The primary issue prompting this recall is a defect identified in the product's blister pack. This packaging flaw could potentially compromise the sterility or integrity of the ophthalmic solution, which is intended for sensitive intraocular surgical procedures. While the document doesn't specify an inspection date, the recall announcement was published on October 18, 2024. Under the NMPA's regulatory framework, a Class II recall signifies that the product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Hyaltech Ltd. is taking the required action of voluntarily recalling the affected product. It is important to note that the specific models, specifications, and batches involved were not imported into China, mitigating direct domestic impact within China. Further details are available in the accompanying 'Medical Device Recall Event Report Form'.