China NMPA Product Recall - Central aperture posterior chamber refractive intraocular lens

STAAR Surgical AG, Switzerland, through its local entity STAAR Surgical (Shanghai) Co., Ltd., has announced a voluntary Class II recall concerning its Central Foramen Posterior Chamber Refractive Intraocular Lenses, known commercially as the COLLAMER IMPLANTABLE CONTACT LENS (National Medical Device Registration Certificate No. 20143165000). This recall, publicly reported by the National Medical Products Administration (NMPA) on December 28, 2023, stems from a critical quality issue. The core problem identified is a refractive error, specifically that the measured modulation transfer function (MTF) value of the lenses was found to be below its predetermined minimum acceptable limit. The MTF is a crucial metric for evaluating the optical quality and image clarity of a lens, and its deficiency can directly affect visual outcomes for patients. As a Class II recall, this indicates that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company has initiated this action to uphold product efficacy and patient safety standards under the regulatory oversight of the NMPA. Comprehensive details regarding the specific affected product batches, specifications, and required actions are outlined in the official "Medical Device Recall Event Report Form".