China NMPA Product Recall - Aspheric intraocular lens, aspheric intraocular lens, spherical intraocular lens

Oculentis B.V., an intraocular lens manufacturer, initiated a Class III voluntary recall of its aspheric and spherical intraocular lenses, including models L-312, L-313, and PCA81, with expiration dates spanning January 2017 to May 2020. This recall, reported to the National Medical Products Administration (NMPA) on September 27, 2017, and published on October 10, 2017, was prompted by patient reports of intraocular lens opacity occurring in the later postoperative period. This issue potentially affects the optical transparency of the lenses, leading to a gradual decline in vision. The recall affects approximately 520,000 units globally, with 54,858 products sold in China. Beijing Gaoshi Yuanwang Technology Co., Ltd. is the agent managing the recall within China. Corrective actions include immediately stopping sales and use of unimplanted stock, recalling all affected products, and providing free replacements with new products. Affected batches will be destroyed. For patients with implanted lenses that develop significant clouding affecting vision, Oculentis B.V. committed to providing necessary assistance, including free replacements if IOL replacement surgery is required. This measure was taken proactively to mitigate potential patient risks.