Sierra Vision System® Phaco-Vitrectomy一体机获NMPA批准：Sierra Medical Advances Integrated Ophthalmic Surgical Solutions with Full-Stack In-House Technology

Recently, Sierra Medical'sSIERRA VISION SYSTEM^® Phacoemulsification and Vitrectomy Integrated MachineOfficially obtained the Class III Medical Device Registration Certificate from the National Medical Products Administration (Registration No.: 20263160759).

As one of the core devices in ophthalmic surgical systems, the approval and implementation of this product marks that domestically produced high-end ophthalmic surgical equipment is moving from the single instrument stage into an era of..."A New Phase Oriented Towards 'Comprehensive Solutions'."

This is not only a breakthrough at the product level, but also reflects the further enhancement of system capabilities and engineering integration capabilities by domestic manufacturers.

# Full-Stack Self-Developed Technology Platform

The realization of an all-in-one machine essentially relies on the deep collaboration and long-term accumulation of multiple technical modules.

From the perspective of technical architecture, the system is built on three core platforms:

• Fluid Platform：Airway Module Drive - A First in China20K Dual-Blade Dual-Airflow Ultra-High-Speed Vitrectomy Probe, Efficiently Driven by Fluid ModuleLiquidCirculate andMaintaining stable intraocular pressure during surgery is the foundation for safe operation.；

• Optical Platform: Undertake the functions of intraoperative visualization and energy transmission,Further enhancedOperational Precision and Tissue Response；

• Energy Platform: Corresponding CrystalStatusEmulsification andElectrocoagulationKey steps such as hemostasis。

On this basis, the equipment is further integrated.Vitrectomy,Modules such as ultrasound, laser, electrocoagulation, and illumination enable it to cover the core operational procedures in cataract and vitreoretinal surgeries., with a relatively complete configuration of functional modules.

This kind of transformation from underlying technology to system integrationSelf-developedPath, making all-in-one machines no longer just"Functional combination," but more akin to an integrated solution built around clinical workflows.

In terms of配套耗材, Sierra Medical relies on a complete layout of consumables, forming a multi-dimensional product portfolio that effectively addresses clinical access.Medical InsurancePain points in the industry, such as charging. Particularly prominent is that, unlike some brands in the track that rely on OEM and piecing together consumables,Sierra Medical achieves full-series self-research and self-production of consumables, ensuring product technical stability and secure, controllable supply chains from the source.

Through continuous technical accumulation and patent layout, the company gradually realizes the transition from key consumables to core equipment.Entire ChainIndependent配套，使整体系统在结构与性能上ComprehensiveHas the foundation to be on par with international top-tier equipment.，Breaking the Import Monopoly,To provide technical support for the localization of high-end medical equipment in China, and to promote the process of domestic substitution in the ophthalmic medical field.

# Dual Validation of Clinical Evidence and Quality System

Unlike most devices, the reliability of system-level products is not only reflected in the parameter level but also in their stable performance in real surgical environments.

In advancing the research and development of its products, Sierra Medical continuously strengthens the construction of its clinical evidence-based system. It conducts multiple clinical studies around vitrectomy probes and surgical platforms, while accumulating and validating data on an ongoing basis.

This clinical-driven R&D approach extends product validation from the laboratory to real-world application scenarios, becoming an important differentiator from some similar manufacturers.

At the same time, the company is continuously improving its quality system and production capacity throughStandardized Intelligent Manufacturing and Ten-Thousand-LevelGMP Facility Construction`, providing a fundamental guarantee for the consistency and large-scale delivery of equipment.`

Against the backdrop of continuously increasing system complexity, this"Evidence-Based"+ Manufacturing" dual capabilities, becoming an important support for the long-term reliable operation of equipment.

# From Single Device to Comprehensive Solutions

Unlike the traditional product logic centered on a single device, Sierra Medical has positioned itself as a provider of comprehensive solutions for anterior and posterior segment surgeries in ophthalmology from the very beginning.

On the basis of已完成关键耗材布局，如玻切头、穿刺器及激光光纤, the approval of the phacoemulsification and vitrectomy一体机 enables a critical补充in the equipment端, gradually forming a系统能力that covers主要手术环节.

At the same time, around phacoemulsification machines, digital surgical microscopes, and intraoperative imaging (iOCT) and other product lines are also advancing, extending the overall solution from "single-point connection" to "systematic synergy."

This approach is not centered around a single product but focuses on building capabilities for the entire surgical procedure.

# Long-term Technical Barriers Built with High Investment

The formation of system-level devices often relies on continuous R&D investment and the accumulation of engineering capabilities.

From the development path, Sierra Medical has maintained a high level of R&D investment and technology layout since its establishment:

The cumulative financing scale has approachedR&D investment continues to increase with 300 million yuan, while multiple patent reserves have been formed around core devices and system platforms.

ThisThe strategy of "emphasizing research and development, emphasizing investment" has enabled it to gradually enter the first tier in the same track in terms of technology platform construction and product iteration rhythm.

For high-complexity equipment like phaco-vitrectomy machines, funding and R&D capabilities are not short-term variables but key factors that determine the product's upper limit.

Conclusion

From vitrectomy probes, trocars, and laser fibers to the recently approved phaco-vitrectomy machine, Sierra Medical's product trajectory is progressively moving from individual devices towards a systematic platform.

In the process of Chinese-produced ophthalmic devices continuously extending to high-end equipment, this advancement approach—guided by comprehensive solutions, based on technological platforms, and supported by clinical evidence—is providing the industry with a different developmental path.

Its subsequent performance in clinical applications and market implementation is also worth continuous attention.Follow。