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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Bausch + Lomb Bi-Blade+ Vitrectomy Cutter and Stellaris Elite Fluidics Update

The 510(k) covers a faster dual-port cutter for retina and cataract surgery and an automated infusion-pressure feature on the company's Stellaris Elite surgical platform.

By News DeskApril 9, 20262 min read
An ophthalmologist preparing surgical equipment before eye surgery
A US Air Force ophthalmologist prepares surgical equipment before a vitrectomy in Guyana in March 2026. The equipment shown is not identified as the Bausch + Lomb system described in this article. Staff Sgt. Dakota Carter/US Air Force, Public domain, via Wikimedia Commons · Public domain (work of the US federal government)
FDA cleared510(k) · K252052FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared Bausch + Lomb's Stellaris Elite system with the Bi-Blade+ vitrectomy cutter under 510(k) K252052, with a decision dated March 25, 2026.
  • The company says Bi-Blade+ runs at up to 25,000 cuts per minute and delivers a 25% higher flow rate than the original Bi-Blade, based on bench and preclinical data.
  • The 510(k) cites the earlier Stellaris Elite system and the original Bi-Blade cutter as predicate devices.

The US Food and Drug Administration has cleared Bausch + Lomb's Bi-Blade+ dual-port vitrectomy cutter and an Adaptive Fluidics update to its Stellaris Elite Vision Enhancement System, the eye-care company announced on April 8, as reported by Retinal Physician.

A vitrectomy cutter is a small probe that cuts and removes the gel-like vitreous from inside the eye during retina surgery. The Stellaris Elite is the console that powers the cutter and manages fluid flowing into and out of the eye.

What the FDA record shows

The FDA's 510(k) database lists the clearance as K252052, a traditional 510(k) for the Stellaris Elite vision enhancement system that the agency received on July 1, 2025. The decision, substantially equivalent, is dated March 25, 2026. The device falls under the phacofragmentation unit product code, with vitreous aspiration and cutting instruments among its subsequent codes, and was reviewed by the ophthalmic panel.

According to the clearance letter and 510(k) summary, the submission covers both the Stellaris Elite system and the Bi-Blade+ cutters. The summary names two predicate devices: the previous Stellaris Elite system, cleared under K240169, and the original Bi-Blade Vitrectomy Cutter made by Medical Instrument Development Laboratories, cleared under K153168.

The summary describes Bi-Blade+ as a guillotine-style cutter driven by a pneumatic pulse, with dual side ports and an aspiration channel, sterilized by gamma radiation. The system is intended for removing cataracts and for anterior and posterior segment vitrectomy, and can be fitted with a laser module for retinal photocoagulation and laser trabeculoplasty. Separate cutter packs are intended for anterior, posterior and combined procedures.

The company's performance claims

Bausch + Lomb said the new cutter raises cutting speed to 25,000 cuts per minute while keeping a 100% open duty cycle, Retinal Physician reported. The company said the device delivers a 25% higher flow rate than the earlier Bi-Blade, and that bench and preclinical data showed a 62% reduction in cutter vibration at maximum speed. These figures come from the company and from conference posters and abstracts it cited, not from a clinical trial reviewed for this article.

The Adaptive Fluidics update adjusts infusion automatically in response to real-time changes in vacuum. The company said that, used together, the two features reduced infusion pressure and kept intraocular pressure more stable in testing.

"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," said Marco Mura of the University of Ferrara in Italy, quoted in the company's release.

The company did not give US pricing or a launch date in the material Health Sense reviewed.

Sources

  1. Stellaris System Upgrades Receive 510(k) Clearance, Retinal Physician, April 8, 2026
  2. 510(k) K252052: Stellaris Elite vision enhancement system (database record), US Food and Drug Administration, March 25, 2026
  3. K252052 clearance letter and 510(k) summary, US Food and Drug Administration, March 25, 2026