en.Wedoany.com Reported - On the evening of June 2, Shanghai Haohai Biological Technology Co., Ltd. announced that its controlled subsidiary, Henan Semisight Biotechnology Co., Ltd., has obtained the medical device registration certificate issued by the National Medical Products Administration (NMPA) for its trifocal intraocular lens product. The product, marketed under the brand name "Xiangwujie," is intended for vision correction in aphakic eyes of adult cataract patients, improving near, intermediate, and distance vision while reducing dependence on glasses.
This approval allows Haohai Shenke to further expand its product matrix in the high-end intraocular lens segment. Intraocular lenses are core implantable medical devices in cataract treatment. Traditional monofocal products primarily address distance vision restoration, while multifocal and trifocal intraocular lenses cater to patients' postoperative needs for vision at multiple distances. The technical barriers lie in optical design, material stability, processing precision, light energy distribution, and visual quality control.
According to public information from the NMPA, the trifocal intraocular lens approved for Henan Semisight is a one-piece posterior chamber intraocular lens, foldable, with an optimized C-loop haptic design. The optic and haptics are made of hydrophobic acrylate copolymer material, with the addition of ultraviolet and partial blue light absorbers. The optical design features a trifocal, aspheric configuration. The product is intended for vision correction in aphakic eyes of adult cataract patients, with implantation in the capsular bag. For ophthalmic medical device companies, obtaining registration approval for such products not only signifies market access for a single product but also confirms that the company has passed regulatory verification in materials, optical design, production processes, and clinical evaluation. Haohai Shenke has previously established a presence in medical biomaterials fields such as ophthalmology, medical aesthetics, orthopedics, anti-adhesion, and hemostasis. Its ophthalmology business covers areas including cataracts, myopia prevention and control, refractive correction, and ocular surface. Henan Semisight is a key subsidiary in its intraocular lens segment.
The market value of such high-end intraocular lenses stems from the simultaneous increase in demand for cataract treatment and patients' postoperative visual quality requirements. With the aging population and advancements in ophthalmic surgical techniques, cataract treatment has evolved from simply restoring vision to increasingly focusing on a continuous visual experience at far, intermediate, and near distances, as well as enhanced convenience in daily life. Trifocal intraocular lenses can cover multiple viewing distances simultaneously but also impose higher requirements on companies' diffractive design, aberration control, material purity, and batch manufacturing consistency. For China's intraocular lens industry, high-end products have long been dominated by multinational corporations. For domestic companies to achieve more stable clinical adoption, they need to continuously build trust through registration approvals, real-world usage feedback, physician training, channel coverage, and postoperative visual quality validation. Following the approval of Haohai Shenke's "Xiangwujie," it will help the company form a more complete product portfolio in the high-end intraocular lens market and expand the range of options for domestic products in refractive cataract surgery scenarios.
Subsequent progress will depend on product launch and promotion, hospital access, physician usage feedback, and patient suitability. Trifocal intraocular lenses are high-end implantable medical devices. Commercialization depends not only on the registration certificate but also on channel coverage, surgeon awareness, pricing systems, medical insurance and procurement policies, and long-term safety monitoring. As the NMPA continues to strengthen post-market surveillance, companies also need to accumulate data in quality control and clinical usage feedback to advance high-end cataract treatment products from approval to stable application.
This article is compiled by Wedoany. All AI citations must indicate the source as "Wedoany". If there is any infringement or other issues, please notify us promptly, and we will modify or delete it accordingly. Email: news@wedoany.com
