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Constellation® ultravit® and hypervit® vitrectomy probe

Official notice

26 Sept 2025

Last checked

26 Sept 2025

Critical riskHealth Canada

An official Health Canada notice concerns Constellation® ultravit® and hypervit® vitrectomy probe. Alcon is conducting a voluntary medical device field safety corrective action for specific models of Constellation® UltraVit® (10k) and HyperVit® (20k) vitrectomy probe as there is potential for probes to unexpectedly fail to actuate and cut during use. There is a remote chance that an adverse event may occur if a probe unexpectedly fails to actuate and cut during surgery. Depending on the position of the cutter when the issue occurs and the amount of suction pressure applied by the probe, there is a potential for increased traction on the vitreous and/or retina that could lead to holes/tears. Published 2025-09-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

78133

Official notice

2025-09-26

The hazard

Alcon is conducting a voluntary medical device field safety corrective action for specific models of Constellation® UltraVit® (10k) and HyperVit® (20k) vitrectomy probe as there is potential for probes to unexpectedly fail to actuate and cut during use. There is a remote chance that an adverse event may occur if a probe unexpectedly fails to actuate and cut during surgery. Depending on the position of the cutter when the issue occurs and the amount of suction pressure applied by the probe, there is a potential for increased traction on the vitreous and/or retina that could lead to holes/tears.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

78133

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Affected products

Product 1

Affected products - Probe, Posterior Vit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8065752413

Product 2

Affected products - Probe, Posterior Vit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8065752415

Product 3

Affected products - Probe, Posterior Vit, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8065752417

Product 4

Affected products - HyperVit® Bevel Vitrectomy Probe, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8065830026

Product 5

Affected products - HyperVit® Bevel Vitrectomy Probe, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 8065830027

Risk / hazard

Alcon is conducting a voluntary medical device field safety corrective action for specific models of Constellation® UltraVit® (10k) and HyperVit® (20k) vitrectomy probe as there is potential for probes to unexpectedly fail to actuate and cut during use. There is a remote chance that an adverse event may occur if a probe unexpectedly fails to actuate and cut during surgery. Depending on the position of the cutter when the issue occurs and the amount of suction pressure applied by the probe, there is a potential for increased traction on the vitreous and/or retina that could lead to holes/tears.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand: Alcon Laboratories, Constellation® Ultravit® And Hypervit® Vitrectomy Probe.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

critical

Recall details

Recall number

78133

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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