Bausch + Lomb secures FDA clearance for advanced vitrectomy technology

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Bausch + Lomb secures FDA clearance for advanced vitrectomy technology
Bausch + Lomb secures FDA clearance for advanced vitrectomy technology
Heidi Cuthbert
Written by Heidi Cuthbert
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Bausch + Lomb (NYSE:BLCO), a leader in eye health, announced on April 8, 2026, that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Bi-Blade+ dual-port vitrectomy cutter and an advanced Adaptive Fluidics update for the Stellaris Elite® Vision Enhancement System.

The next-generation Bi-Blade+ represents a significant leap in retinal surgery performance, increasing cutting speeds to 25,000 cuts per minute (CPM)—a substantial rise from the 15,000 CPM featured in the previous Bi-Blade model.

This speed, paired with a 100% open duty cycle, allows for a 25% increase in flow rate, enabling surgeons to remove vitreous more efficiently during complex retinal procedures.

Beyond speed, the Bi-Blade+ focuses on precision and ergonomics.

Bausch + Lomb reported that at maximum speed, the new cutter demonstrates a 62% reduction in vibration compared to its predecessor.

This improvement is designed to provide surgeons with an optimized feel and enhanced stability during delicate intraocular maneuvers.

Complementing the hardware is the new Adaptive Fluidics update.

This software-driven enhancement automates fluid infusion to the eye by responding in real-time to the surgeon’s vacuum commands.

By delivering precise, responsive infusion at every stage of the procedure, the system helps maintain consistent intraocular pressure (IOP).

Clinical studies cited by the company indicate that the combination of these technologies resulted in a 62% reduction in average infusion pressure compared to procedures without Adaptive Fluidics.

Furthermore, the system demonstrated an ability to maintain chamber IOP at ranges closer to physiologic levels (10–20 mmHg), even when operating at high vacuum levels.

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