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

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Oculentis B.V. for its aspheric and spherical intraocular lenses. This recall, reported on September 27, 2017, and published on October 10, 2017, addresses a critical product performance issue. The main concern arose from notifications that some patients experienced intraocular lens opacity, or clouding, in the later postoperative period. This defect could compromise the optical transparency of the lenses, potentially causing a gradual decline in vision. Affected products, including models L-312, L-313, and PCA81, have expiration dates between January 2017 and May 2020. Beijing Gaoshi Yuanwang Technology Co., Ltd. serves as the agent for these products in China. Oculentis B.V. implemented several required actions: notifying distributors to immediately cease sales, recall all unimplanted affected stock, and provide free replacements with new products. Furthermore, the company committed to destroying all returned faulty batches. For patients with implanted lenses experiencing significant vision impairment due to clouding, Oculentis B.V. will offer necessary assistance, including free lens replacements if surgical intervention is needed.