Model note · Vitrectomy System

Alcon CONSTELLATION Vision System

Name: Alcon CONSTELLATION Vision System
Brand: CONSTELLATION

CONSTELLATION is Alcon's modular ophthalmic microsurgery console used in eye theatres for vitreoretinal surgery and also for cataract (phaco) work, combining infusion, vitreous cutting, aspiration, illumination, diathermy and an optional embedded 532 nm laser. It is known for active IOP control using a non-invasive flow sensor, and for high-speed single-use cutter probes up to 20,000 cuts per minute with the HYPERVIT dual-blade probe.

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The model

Maker, model and type.

Maker: Alcon Research, Ltd. (Alcon)
Model: Alcon CONSTELLATION Vision System
Device type: Vitrectomy System
Main document: Open the public document

Key specifications

What the public record says.

Item	Value	Source
Functions	Infusion, vitreous cutting, aspiration, illumination, irrigation, lens emulsification and fragmentation, cautery and diathermy	Source
IOP control	Proprietary non-invasive flow sensor; Alcon states IOP held within 2 mmHg, compensating infusion pressure	Source
Cutter speed	Advanced ULTRAVIT up to 10,000 cpm; HYPERVIT dual-blade up to 20,000 cpm (maximum core mode)	Source
Probe gauges	25+ and 27+ gauge	Source
Laser	Optional embedded PurePoint 532 nm laser controlled from the console, with LIO compatibility	Source
Infusion and vacuum range (reseller sheet)	Infusion 0 to 120 mmHg; aspiration 0 to 650 mmHg	Source
Consumables	Single use, EtO or gamma sterilised; reusable handpieces supplied non-sterile	Source
Regulatory class	FDA Class II, 21 CFR 886.4150 (HQE) and 886.4670 (HQC)	Source
Power and weight (reseller sheet)	12 A max at 100 to 120 V, 7.5 A max at 220 to 240 V; tabletop about 61.2 kg	Source

Recalls

Known FDA recalls.

Z-1924-20102010-04-30
Performance and settings issues could cause unexpected shutdown, unresponsive touchscreens and fluidics problems (with sister entries for each configuration).
FDA record
Z-1506-20132013-04-17
Pneumatic handpiece (725.01): forceps or scissors tips could dislodge if not attached per directions.
FDA record
Z-1693-20162015-08-11
23G and 25G TotalPlus paks could leak beyond design specification.
FDA record
Z-1794-20202018-07-25
20 GA TotalPlus combined pak could contain a 25 gauge infusion cannula instead of 20 gauge.
FDA record
Z-0099-20242023-08-18
New PCB design could over-volt a component, causing loss of pressure control for cutters, scissors and forceps.
FDA record
Z-0490-20252024-10-15
Breakage of the tubing anti-reflux valve from improper use; labelling changed.
FDA record
Z-0304-20262025-08-05
Accessory devices for Unity and Constellation: incomplete pouch seals compromising the sterile barrier.
FDA record

Safety

Safety warnings from the record.

Loss of pressure control from the affected PCB could raise the risk of infection, tissue damage and visual impairment. Source
Consumables are sterile and single use only; do not reuse probes or paks. Source
Reusable handpieces are supplied non-sterile and must be reprocessed with Alcon's validated instructions. Source
Check pak contents match the planned gauge; recalls found the wrong gauge probe or cannula packed in some paks. Source

Sources

Where this note comes from.

Not covered: The CONSTELLATION operator's manual and service manual were not public, so console alarm and error messages, utility requirements and the service test procedure are not included; infusion and vacuum ranges come from a reseller sheet only.

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