Key Takeaways

• Zeiss received NMPA approval for PT Lunana, its first phakic IOL, with commercialization in China planned for 2027

• The lens features an aspheric optical design, Aquaflex hydrophilic polymer material, seven sizes, and 0.25-D power increments

Zeiss Medical Technology has received approval from China's National Medical Products Administration (NMPA) for its PT Lunana phakic IOL, marking the company's entry into the phakic IOL market. Zeiss plans to commercialize the lens in China in 2027, with eventual expansion into global markets.

The company showcased PT Lunana at the 9th China International Import Expo in Shanghai. The lens combines an aspheric optical design with Aquaflex hydrophilic polymer material, designed to provide flexibility, optical clarity, and stability. PT Lunana is intended to expand refractive correction options for patients with myopia, including those with high myopia or thin corneas who may not be suitable candidates for laser vision correction. The lens is available in seven sizes and 0.25-diopter power increments.

According to Zeiss, PT Lunana has completed premarket clinical trials and 2 years of follow-up across nine Grade 3A hospitals in China. 

The approval comes amid substantial demand for myopia management and refractive correction in China. A 2025 systematic review and meta-analysis reported a myopia prevalence of 67.2% among individuals aged 15 to 19 years, including 9.5% with high myopia.¹

PT Lunana represents the first product in Zeiss's planned phakic IOL portfolio, complementing its existing refractive technologies, including Smile Pro.

Reference

1. Pan W, Saw SM, Wong TY, Morgan I, Yang Z, Lan W. Prevalence and temporal trends in myopia and high myopia children in China: a systematic review and meta-analysis with projections from 2020 to 2050. Lancet Reg Health West Pac. 2025 Jan 27;55:101484. doi: 10.1016/j.lanwpc.2025.101484