China NMPA Product Recall - Central aperture posterior chamber astigmatic phakic intraocular lens

The National Medical Products Administration (NMPA) has announced a Level II voluntary recall initiated by STAAR Surgical AG, a medical device manufacturer based in Switzerland. This recall pertains to their Implantable Collamer Lenses for Posterior Chamber Astigmatism, specifically those holding National Medical Device Registration Certificate No. 20253160212. The recall, reported by Dashi Eye Care Equipment (Shanghai) Co., Ltd., the distributor, was published on February 2, 2026. The primary issue prompting this action was the identification of a quality defect within a specific batch of these lenses. It was discovered that seven lenses, including both 12.6mm and 12.1mm sizes from the same production batch, exhibited a quality inferior to the established standard for 12.1mm lenses. This indicates a manufacturing inconsistency or deviation from product specifications, leading to potentially compromised device performance. Under the regulatory oversight of the NMPA, STAAR Surgical AG has taken proactive measures to address this product deficiency by implementing a voluntary recall. A Level II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further details regarding the specific models, specifications, and batch numbers affected are provided in the accompanying Medical Device Recall Event Report Form. This action underscores the commitment to patient safety and adherence to product quality standards within the medical device industry.