BVI Earns CE Mark for its First Dual-Function Phaco-Vitrectomy Platform

BVI has received CE Mark approval for Virtuoso, a next-generation phaco-vitrectomy surgical platform and dual-function system designed to support both cataract and vitreoretinal procedures on a single, integrated platform.

Virtuoso introduces a new level of control through novel fluidics, consistent energy delivery, advanced vitreous cutting and aspiration performance, and a seamless Operating Room (OR) workflow, according to the company. CE Mark certification under MDR represents a major milestone in BVI’s continued expansion in the premium surgical equipment segment and its broader mission to support surgeons with flexible, future-ready solutions, bigwigs claim.

“Virtuoso represents a significant advance in surgical equipment design, bringing together precision, intuitive ease of use that supports OR efficiency, and world-class versatility for both the front and the back of the eye,” BVI President/CEO Jim Hollingshead said. “With CE Mark certification under the European Medical Device Regulation, we are making this platform available to surgeons across Europe, designed to elevate surgical control, efficiency, and outcomes, reflecting BVI’s continued commitment to meaningful innovation in eye health.”

One Platform Designed for Multi-Specialty Excellence

Virtuoso is built to support anterior, posterior, and combined procedures, addressing the evolving needs of multi-specialty centers, ambulatory surgical centers, and high-efficiency operating environments. Key innovations include:

• Equality Fluidics Control. A proprietary intraocular pressure (IOP) management system actively maintains a consistent target IOP throughout all procedural steps.
• Resolute Ultrasound Delivery. An intelligent energy optimization system that delivers target energy regardless of lens hardness.
• Velvet Vitrectomy Probe. A high-speed, dual-pneumatic, dual-blade vitrectomy drive designed for controlled and efficient posterior and anterior vitrectomy.
• EvenFlow Automatic FAX. An automated fluid-air exchange solution providing machine-controlled IOP control during surgical media exchanges.
• inVITe Valved Entry System. A flexible entry system with a high-flow directional infusion cannula to improve surgical efficiency and maintain stable intraoperative fluidics.
• EasyFit All At Once Setup. A streamlined operating room setup to reduce turnover time and improve procedural consistency.

As part of BVI’s commitment to clinical collaboration and evidence generation, Virtuoso is currently being evaluated in a pre-market, prospective, single-center, single-arm clinical investigation at LMU Klinikum in Munich, Germany, led by Professor Siegfried Priglinger, M.D., chair of the Department of Ophthalmology at LMU Klinikum. The first patient procedure was successfully performed in December 2025, marking an important clinical milestone for the platform.

“During this first phase of our clinical evaluation, Virtuoso has demonstrated a thoughtful integration of fluidics stability, responsiveness, and workflow efficiency, designed with the realities of combined cataract and vitreoretinal surgery in mind, and we look forward to further evaluating its performance as the study progresses,” Dr. Priglinger stated.

The 2025 EURETINA, ESCRS, and FloRETINA congresses featured the first-ever Virtuoso abstracts in their scientific programs, presenting data on post-occlusion break surge that demonstrated the system’s responsiveness in recovering IOP stability. Additional findings highlighted energy delivery consistency, supporting the ability to maintain target energy and enabling lower energy setpoints, alongside enhanced aspiration efficiency versus leading platforms in both BSS and vitreous, and higher cutter stiffness without compromising efficiency at high degrees of bending.

Virtuoso is positioned to compete at the highest tier of ophthalmic surgical systems, supporting providers seeking flexible, scalable, and cost-effective platforms. The system further strengthens BVI’s value proposition by seamlessly integrating its expanding portfolio of consumables and intraocular lenses. Commercial availability is expected to begin across Europe in Q3 2026, with expansion into additional international markets planned thereafter.

BVI is an innovator in eye health, with a legacy of shaping ophthalmic care through advanced technology. Building on nearly nine decades of expertise, from foundational surgical instruments to premium intraocular lenses and next-generation platforms, BVI partners closely with surgeons to deliver technology that supports surgical performance and patient care. The company’s products serve surgical teams in more than 90 countries.