Another Phakic Intraocular Lens Enters the Innovative Medical Device Fast-Track

Intraocular refractive surgery does not involve corneal tissue ablation. Instead, a custom intraocular lens (such as those used in ICL implantation) is inserted through a micro-incision into the eye, between the iris and natural crystalline lens. Refractive errors are corrected by adding an intraocular "lens".

At present, the domestic refractive lens market for myopia surgery is almost monopolized by EVO ICL manufactured by STAAR Surgical AG (hereinafter referred to as STAAR), resulting in persistently high overall surgical costs.

Recently, the National Medical Products Administration (NMPA) published the public notice Review Results of Applications for the Special Review of Innovative Medical Devices (No. 6, 2026). The toric posterior chamber phakic intraocular lens independently developed by Wuxi Carl Zeiss Leiming Shikang Medical Technology Co., Ltd. has successfully qualified for the Special Review Procedure for Innovative Medical Devices (the innovative fast-track) managed by the Center for Medical Device Evaluation (CMDE) under NMPA.

In accordance with the Special Review Procedure for Innovative Medical Devices (NMPA Announcement No. 83 of 2018), the Special Review Office for Innovative Medical Devices organized expert panels to assess submitted applications. The following project is proposed to be admitted to the special review procedure, for public notification.

Toric Posterior Chamber Phakic Intraocular Lens

This implantable intraocular lens (Toric ICL) is designed to correct high myopia combined with astigmatism. It is implanted in the posterior chamber, between the patient’s native crystalline lens and iris, without corneal resection, and features reversibility. It is particularly suitable for patients with thin corneas or those ineligible for laser myopia surgery. Jointly developed by Wuxi Leiming Shikang and Carl Zeiss, the product aims to break STAAR Surgical’s absolute monopoly in this segment.

The field of ophthalmic high-end devices has witnessed robust development. Sigma Medical, a leading CRO, has participated in clinical research for multiple intraocular lens products. Database records from SigmaData indicate that driven by breakthroughs in underlying technologies, maturing domestic R&D capabilities and rising cross-border mergers and acquisitions, numerous domestic enterprises have achieved independent development, completed acquisitions or launched self-developed phakic intraocular lenses.

For instance, Medtec acquired Medennium and is advancing the domestic introduction of its MPL lens.

The admission of Wuxi Carl Zeiss Leiming Shikang’s product to NMPA’s Special Review Procedure for Innovative Medical Devices not only validates its cutting-edge technology and outstanding safety profile, but also entitles the product to priority communication, expedited review and targeted regulatory guidance throughout the subsequent registration application process, which is expected to significantly shorten the timeline for the innovative device to reach patients.

The Special Review Procedure for Innovative Medical Devices is designed to advance cutting-edge research and clinical translation in the medical device sector. It imposes stringent requirements on applicants regarding technological innovation, clinical value and intellectual property rights, serving as a rigorous litmus test for industrial innovation.

Leveraging the policy advantages conferred by fast-track qualification, the company will actively and efficiently advance subsequent R&D and registration under professional regulatory guidance to accelerate the product’s path to market launch. Moving forward, the enterprise will continue to deepen its innovative medical device R&D pipeline, contributing expertise to the advancement of the Healthy China Initiative and delivering benefits to patients worldwide.

术语注释: 

1. 有晶体眼人工晶状体：phakic intraocular lens (PIOL)
2. 环曲面后房有晶体眼人工晶状体：toric posterior chamber phakic intraocular lens
3. 创新医疗器械特别审查程序：Special Review Procedure for Innovative Medical Devices
4. 国家药监局医疗器械技术审评中心（CMDE）：Center for Medical Device Evaluation
5. 光学像差：optical aberrations
6. 房水循环：aqueous humor circulation
7. CRO：Contract Research Organization 合同研究组织
8. 健康中国：Healthy China Initiative
9. 屈光不正：refractive errors
10. 微切口：micro-incision