Bausch + Lomb Secures FDA 510(k) Clearance for Bi-Blade+ Dual-Port Vitrectomy Cutter

The U.S. Food and Drug Administration has granted 510(k) clearance to Bausch + Lomb Corporation’s Bi-Blade+ advanced dual-port vitrectomy cutter and the Adaptive Fluidics advanced update on the Stellaris Elite Vision Enhancement System.

“Retinal surgeons who are familiar with our Bi-Blade technology understand the benefits of its dual-port design, 100% open duty cycle and cutting speed of 15,000 cuts per minute,” said Wayne Caulder, vice president and general manager, North America Surgical, Bausch + Lomb. “Bi-Blade+ offers these features along with an increased cutting speed of 25,000 cuts per minute. When combined with Adaptive Fluidics, surgeons will experience stability, efficiency and control that will help streamline procedures and deliver exceptional patient outcomes.”

Bi-Blade+’s increased cutting speed of 25,000 cuts per minute¹ aims to minimize retinal traction,² increase vitreous flow,¹ and reduce infusion pressure fluctuations when used with Adaptive Fluidics.^3* Bi-Blade+ provides a 25% increased flow rate, thus enabling more efficient vitreous removal compared to Bi-Blade.^1* At maximum speed, Bi-Blade+ also demonstrates a 62% reduction in cutter vibration compared to Bi-Blade, offering surgeons an optimized feel and comfort toward a stable surgical experience.⁴

The Adaptive Fluidics update automates fluid infusion to the eye in response to real-time vacuum commands from the surgeon, delivering precise and responsive fluidics infusion at every step of a vitrectomy procedure.

These two technologies combine to support and maintain intraocular pressure (IOP) stability and control. When combined with Adaptive Fluidics, Bi-Blade+ demonstrated a 62% reduction in average infusion pressure compared with surgeries in which Adaptive Fluidics was not used.³ Continuous aspiration also provides consistent IOP stability.^3** In one study, Bi-Blade+ with Adaptive Fluidics resulted in a significant improvement in chamber IOP at a range closer to physiologic IOP (10 – 20 mmHg) even during high vacuum levels.^3***

“Bi-Blade has been an essential tool for me in a variety of surgeries, including core vitrectomies, vitreous shaving near mobile retina, removal of intraocular tissues, and dissections,” said Professor Marco Mura, M.D., University of Ferrara in Ferrara, Italy. “The increased cut speed that Bi-Blade+ offers paired with the additional control of Adaptive Fluidics promises to further promote stability and efficiency during surgery.”

The Bausch + Lomb vitrectomy cutter pouches are intended to cut and remove vitreous from the eye. They are indicated for any ocular condition requiring anterior vitrectomy during anterior segment surgery and for any vitreoretinal condition requiring vitrectomy during posterior or combined surgery. Stellaris Elite Bi-Blade+ accessories are only intended to operate with Bausch + Lomb Stellaris Elite vision enhancement systems with Bi-Blade+ procedure pack compatibility.

Bausch + Lomb has evolved with the changing needs of patients and customers for nearly two centuries, and it strives to improve the standard of eye health care. The company’s offerings include contact lenses, prescription products, over-the-counter options, surgical devices, and more,

* Based on bench and animal testing
** Based on bench testing
*** Based on bench testing comparing original Bi-Blade to single-port cutter.

References
¹ Heuer R, Papour A, Higgins G. Vitrectomy flow performance and optimized system settings for retina shaving with 25g, 25,000cpm dual-action vitrectomy probes. Poster presented at: ARVO conference; May 2025; Salt Lake City, UT.
² Higgins G, Papour A. Comparison of traction, sphere of influence, and pulsatile flow in-vitro vitrectomy using 25 ga 25,000 CPM dual action vitrectomy probes and 25ga 7,500 CPM single action vitrectomy probes. Poster presented at: ARVO conference; May 2025; Salt Lake City, UT.
³ Papour A, Hosten L. Intraocular pressure (IOP) optimized performance settings with posterior adaptive fluidics (PAF), and 25 gauge 25,000 cpm dual-action vitrectomy cutters. Invest Ophthalmol Vis Sci. 2024;65(7). Association for Research in Vision and Ophthalmology 2024 abstract 914.
⁴ Data on file/