Haisco Pharmaceutical's Subsidiary Launches China’s First Five-Focus Intraocular Lens with Near-100% Light Efficiency
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Shanghai Haohai Biotechnology Co., Ltd.(Abbreviation: "Haohai Biotech",06826.HK，688366.SH）Wholly-owned subsidiaryHenan Universe Intraocular Lens Research Co., Ltd.TheMultifocal Aspheric Intraocular Lens (Trade Name: FullVision®) Approved for Marketing by China's National Medical Products Administration。
The product adoptsFourier HarmonicsFive FociDiffraction Patent Technology, achieving nearly 100% light energy utilization under the condition of pupil diameter less than 3.5mm, becoming the world's first approved intraocular lens based on this technical route.
# From "Spectral Loss" to "Light Energy Reconstruction"
Traditional multifocal intraocular lenses commonly adopt a Fresnel diffraction design — achieving light energy distribution through a stepped structure of concentric rings. The physical limitation of this design lies in the difficulty of precisely manufacturing sharp steps, resulting in partial light energy loss as stray light, with diffraction efficiency typically around 80%-88%.
The technical breakthrough of FullVision® lies in the introduction of mathematical tools into optical design.Through 12 Fourier harmonic components with different amplitudes, phases, and frequencies,To make the light field form constructive interference at five target focal points, the diffraction surface is continuously differentiable in optics, and the edge does not need sharp steps and can be made smooth and rounded. This change directly enhances the processing friendliness and reduces the light energy loss caused by insufficient processing accuracy.
The core innovation is not simply about increasing the number of focal points, but ratherReorganizing "Failed" Light Energy——Redistribute approximately 12%-14% of the lost light energy in the traditional trifocal design to the two transitional power zones of +0.8D and +2.4D.Increase the mid-range light energy utilization rate from 17%-22% to 36%。
# Five Foci ≠ More Interference
The clinical trial of this product was led by Professor Yu Ayong from the Eye Hospital of Wenzhou Medical University and completed in eight top hospitals in China, involving 188 subjects. The control group used imported trifocal intraocular lenses, with a follow-up period of 12 months.
Visual Performance: At 12 months postoperatively, the distance, intermediate, and near uncorrected visual acuities of FullVision® were all better than 0.2 LogMAR, meeting the ISO standard requirements for full-range vision. The defocus curve test showed,Visual acuity performance was better than the control group in China.(P=0.03), with clear focal lines in the distal and proximal transition zones.
Visual Quality: Under dim light conditions, FullVision®The best-corrected visual acuity at far, intermediate, and near distances was significantly better than that of the control group., with a higher proportion of excellent and good intermediate vision. Halos simulation test shows no difference in glare compared to the control group, and contrast sensitivity and anti-glare interference ability are better than the first and second generation trifocal products.
Patient Report：98.9% of users reported improved visual quality., 95.5% expressed "very satisfied" or "relatively satisfied" with postoperative visual quality, and 95.5% successfully achieved spectacle independence.
Moreover, investigators had been concerned that the five-focus distribution might affect resolution, brain analysis, and contrast sensitivity before the clinical trial, but the results negated this hypothesis.
# Technology Positioning in the High-End Market
The approval of Haohai Bio-Sci marks the technical stratification of domestically produced intraocular lenses in the high-end market.
First Tier (Single Focus/Astigmatism Correction): The substitution rate of domestically produced products is relatively high, with sufficient coverage by centralized procurement, and price competition being the main factor.
Second Tier (Bifocal): Aibo Medical's bifocal product enters the centralized procurement, and domestically produced products begin to penetrate. This level provides two clear focal points for distance and near vision, with a light energy splitting design.
Third Tier (EDOF/Continuous Vision): Currently, three domestically produced EDoF IOLs have been approved in China, respectively from Raymon Syntech, Century Contay, and Aibono De. This category provides a continuous range of vision through a single extended focal point, reducing visual disturbances compared to bifocal lenses.
Fourth Tier (Trifocal/Pentafocal): The trifocal market is still dominated by Alcon, Zeiss, and Johnson & Johnson; the pentafocal product marks the first breakthrough by a domestically produced innovation, with Haohai BioScience becoming the world's first company to achieve industrialization of this technological route.
Differentiated competition in technical routes is taking shape.: Century KANGTAI launched the "Intelligent Targeted Light Field Distribution" trifocal Plus, with a light energy utilization rate of over 90%; while Haohai BioSciences achieved a five-focus design through Fourier harmonics, with nearly 100% light energy utilization. Both are striving to find the optimal balance between "number of focal points" and "light energy efficiency."The technology competition in the high-end market is shifting from "engineering optimization" to "innovation in physical principles."
# High-End Breakthrough in the Context of Centralized Procurement
The timing of QuanShiJia®'s approval is noteworthy. The national centralized procurement of intraocular lenses has entered its second phase, with a new round of procurement set to launch in the first half of 2026, and the pressure for price reductions is evident.
Haohai Biotech noted in the announcement that the product has not yet generated sales and will not have a significant impact on the company's performance in the short term. This statement reflects the commercialization challenges faced by high-end products:Even with technological breakthroughs, multiple hurdles remain, such as doctors' usage habits, accumulation of clinical evidence, and medical insurance reimbursement policies.。
But the strategic significance lies in:The Five-Focus Product Provides "Non-Volume Procurement" Pricing Space for Haohai BiotechIf the product can obtain a differentiated payment policy, it can establish a price anchor in the high-end refractive cataract market, offsetting the procurement pressure on mid-to-low range products.
Driven by the global aging population, high-end intraocular lenses (multifocal, EDOF, adjustable, etc.) are expected to contribute 52.7% of the global revenue in this field by 2029. The technological breakthrough of Haohai Biotech is precisely aimed at this structural growth.
The approval of FullVision® marks a pivotal event in the transformation of Chinese-made intraocular lenses from "imitation-following" to "original design." The introduction of Fourier harmonic technology demonstrates the value of mathematical tools in medical device innovation—not merely engineering optimization, but a fundamental rethinking at the level of physical principles.
But technological leadership does not equate to market leadership. Whether the clinical value (intermediate vision continuity) of the five-focus product is sufficient to convince doctors to abandon the mature three-focus product depends on the accumulation of long-term follow-up data and the efficiency of commercial promotion.
For Haohai Biotech, this product is not only a testament to its technical capabilities but also a test of its business model: in an environment where centralized procurement compresses profit margins, whether high-end products can maintain sufficient gross profit margins will determine the success or failure of its transition from "scale expansion" to "value creation."
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