Model note · Vitrectomy System
Bausch + Lomb Stellaris Elite vision enhancement system
Stellaris Elite is Bausch + Lomb's combined cataract and vitreoretinal surgical platform. One console provides phacoemulsification, irrigation and aspiration, bipolar coagulation, vitrectomy up to 7500 cuts per minute, dual endoillumination, viscous fluid injection, air fluid exchange and, in the laser configuration, a 532 nm photocoagulator. Adaptive Fluidics adjusts infusion to hold chamber stability. A 2023 clearance moved the system onto a new computer module running Windows 10.
The model
Maker, model and type.
- Maker
- Bausch + Lomb Incorporated
- Model
- Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
- Device type
- Vitrectomy System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Vitrectomy cut rate | 2500 cpm (BL11145) or 7500 cpm (BL14455, BL15455) | Source |
| Maximum vacuum | 660 mmHg (predicate 600 mmHg) | Source |
| Laser module (BL15455) | 2 W 532 nm diode pumped frequency doubled solid state laser; 0.8 mW 635 nm aiming beam; single, continuous or pulsed | Source |
| Illumination | Two light outputs from two bulbs, Xenon or Mercury; one output has a switchable green, amber or yellow filter | Source |
| Mains supply | 90 to 130 VAC or 200 to 240 VAC, 50/60 Hz | Source |
| Computer platform | Congatec system on module, Windows 10 (replacing Windows XP) | Source |
| Standards | IEC 60601-1, 60601-1-2, 60601-2-2, 60601-2-22 and 80601-2-58 | Source |
| FDA clearance | K232084, product code HQC, decided 26 February 2024 | Source |
Recalls
Known FDA recalls.
- Z-3265-20182018-08-08
Stellaris Elite 20 ga vitrectomy cutter BL5626 (and 23 and 25 ga versions in packs): back cap could separate from the body.
FDA record
Sources
Where this note comes from.
- FDA 510(k) K232084 summary, Stellaris Elite vision enhancement system
- FDA 510(k) K162342 summary, Stellaris Elite
- openFDA recall search, Stellaris Elite
- openFDA MAUDE problem counts, brand Stellaris Elite
Not covered: The operator's and service manuals were not available from an official source, so no on screen messages, error codes, calibration routines or maintenance intervals are given. Recalls on the older Stellaris and Stellaris PC (laser standby software fault, fluidics recalibration) were left out because they name different models. The manufacturerUrl is the company home page, not a product page.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Vitrectomy System
Other models of this device.
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