Bausch + Lomb's New Stellaris Elite Upgrades Approved as Domestic Competitors Enter China's Phaco-Vitrectomy Market
Rhino Health
Developer of High-End Ophthalmic Surgical Equipment
Sierra Medical
Innovative Medical Device Developer
The competition in high-end ophthalmic surgical equipment is changing.
Recently, Bausch + Lomb's Bi-Blade+ Dual-Port Vitrectomy Probe and Adaptive Fluidics Fluid Management System received FDA 510(k) approval as upgraded components for the Stellaris Elite platform.
For the Chinese market, this change is particularly worth noting.
In the past six months, Rhino Health's Genesis I & II and Sierra Medical's SIERRA VISION SYSTEM, two domestically produced phacoemulsification and vitrectomy integrated machines, have successively obtained NMPA Class III registration certificates. Chinese companies are no longer just entering the single equipment or consumables segment but are beginning to challenge the higher threshold market of anterior and posterior segment comprehensive surgical platforms.
# Multinational GiantThe Battle of Systems on Mainstream Platforms
In the global high-end ophthalmic surgical equipment market, companies such as Alcon, Bausch + Lomb, and Carl Zeiss/DORC compete on comprehensive capabilities:Host, consumables, fluid control, energy management, lighting, intraocular pressure compensation, doctor training, after-sales service, and long-term formed doctor usage habits, jointly determining whether a piece of equipment can be used in high-end operating rooms over the long term. The comparison of the three platforms is as follows:
# Chinese-produced phacoemulsification and vitrectomy integrated machines enter the competition
In the past, domestically produced ophthalmic devices were more concentrated in basic examination equipment, some treatment devices, or single-function surgical equipment. High-end phacoemulsification and vitrectomy integrated machines have long been dominated by multinational corporations.
Now, Chinese domestic enterprises are beginning to enter this market.
Rhino Health's Genesis I & IIApproved by NMPA in December 2025 (Registration No. 20253162583), it achieved a key breakthrough for China-produced phacoemulsification and vitrectomy integrated machines, with a maximum vitrectomy speed of 10,000 cpm and bidirectional cutting reaching 20,000 cpm, supporting vitrectomy probes from 20G to 27G. The phacoemulsification adopts a 28.5 kHz low-frequency design with a 1.8 mm incision; integrated with intraocular pressure monitoring, wavelength switching, and ultrasonic vitrectomy functions. In March 2026, it completed a nearly 100-million-yuan Series B financing round for market promotion and registration of the next-generation products.
SIERRA VISION SYSTEM by Sierra MedicalApproved by NMPA in April 2026 (Registration No. 20263160759), positioned as an integrated anterior and posterior segment surgical platform incorporating phacoemulsification, vitrectomy, laser, electrocoagulation, illumination, and other functions, emphasizing the ability to cover the entire process of anterior and posterior segment surgeries without external equipment. Core consumables (vitrectomy probes, trocars, intraocular laser fibers, etc.) have been approved and launched, achieving full-series self-research and self-production. Total financing has reached nearly 300 million yuan.
Tupai Medical "Vega" Series Phacoemulsification and Vitrectomy Integrated MachineAccording to public reports, it has entered the later stage of development and has not yet obtained certification.
New Vision Medical MTP5000Is also in progress, having previously received tens of millions of yuan in investment from Elcon Medical Investment Group.
# Future Observation
The FDA approval for Bausch + Lomb this time is a microcosm. These product lines collectively point to a trend: high-end ophthalmic surgical equipment increasingly emphasizes the coordination capabilities of the entire system. During surgery, doctors assess whether cutting, aspiration, irrigation, illumination, intraocular pressure control, and foot pedal responsiveness are continuous, stable, and smooth. For complex cataract surgeries, vitreoretinal diseases, and combined anterior-posterior segment procedures, equipment stability can significantly influence a doctor’s choice.
This is also the long-term advantage of multinational companies: the comprehensive capabilities formed over years of equipment installation, consumables compatibility, doctor training, after-sales response, and clinical feedback.
China's high-end ophthalmic surgical equipment has finally started to enter the playing field.But the next round of competition will not be decided by who gets the registration certificate first, but by who can still make doctors choose it during the most difficult surgeries.。
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