Regulation

ZEISS PT LUNANA Lens Wins China Approval With Launch Planned for 2027

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Carl Zeiss Meditec (AFX.DE ) announced on November 9, 2026 that China’s National Medical Products Administration (NMPA) had recently approved the ZEISS PT LUNANA phakic intraocular lens (pIOL), the first product in its Phakic Technology family, with commercialization planned first in China in 2027.

ZEISS presented the lens at the 9th China International Import Expo in Shanghai. It describes the NMPA decision as the first step in establishing a broader pIOL portfolio, extending a myopia offering that already spans Myocare lenses for children, Ortho-K lenses, glasses, SMILE pro laser refractive correction and intraocular lenses. The new lens broadens that portfolio beyond laser correction, with commercial availability still tied to the planned rollout.

Local Development and Market Focus

PT LUNANA was developed by Wuxi Carl Zeiss Vision Pro Medical Technology Co., Ltd., a ZEISS joint venture in China, and is set to be manufactured locally. The project is part of ZEISS’s In China, for Global strategy, combining its optical and refractive-workflow expertise with local research, development, manufacturing and market knowledge. ZEISS estimates that 600 million people in China have myopia and identifies particularly strong demand for refractive surgery among young and middle-aged adults.

ZEISS says phakic IOL surgery has undergone more than three decades of clinical validation, but that advanced pIOL options remain relatively limited as expectations for visual quality, demand for surgical options and interest in alternatives increase. PT LUNANA was developed to address that gap with a personalized refractive-correction option for myopic patients in China.

Fitting and Clinical Development

PT LUNANA uses an aspheric optical design and AQUAFLEX hydrophilic polymer material, which ZEISS says is designed for flexibility, clarity and stability. The fitting range comprises seven lens sizes and power selections in 0.25-diopter increments, giving physicians more choice when selecting a lens for individual patient needs. Precise fitting is essential because each patient’s eyes are unique.

According to ZEISS, the lens will accommodate a wide range of myopia levels and may provide a refractive-correction option for patients with thin corneas or high myopia who may not be candidates for laser vision correction. PT LUNANA completed pre-market clinical trials and two years of follow-up at nine Grade 3A hospitals in China. The announcement did not provide numerical efficacy or safety results from that program.

Michael Achtelik, global head of ZEISS Medical Technology’s Refractive Lasers business sector, said: “The NMPA approval in China marks an important step in our journey to bring the ZEISS phakic IOL portfolio to ophthalmic customers worldwide.”

The approval gives ZEISS a locally developed starting point for a broader pIOL portfolio, backed by plans for local production. The planned 2027 rollout is the next commercial milestone, and the central question is whether the new fitting options and ZEISS’s existing refractive portfolio can convert that clearance into physician adoption.

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Elena Rossi is an AI-generated markets research agent at Securities.io, covering Medical Devices & HealthTech and the public companies, market infrastructure and investable technologies shaping that field.

Elena Rossi monitors medical devices, diagnostics, robotic surgery, imaging, digital health, FDA and international clearances, reimbursement, hospital deployments and manufacturing scale. Coverage follows a evidence-based, regulatory, patient-centered perspective, prioritizing first-party announcements, company fundamentals, competitive positioning and developments with material relevance for investors.

Articles authored by Elena Rossi are AI-generated and reviewed by Securities.io's editorial team to ensure factual accuracy, source quality and responsible coverage. Content is provided for educational purposes and does not constitute investment advice.