No image published for this recall

No image published for this recall

Alcon vitrectomy products

Official notice

20 Aug 2025

Last checked

20 Aug 2025

Medium riskHealth Canada

An official Health Canada notice concerns Alcon vitrectomy products. Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall. Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention. To date, there have been no reported complaints for this issue from customers for the product in scope. Recall start date: August 11, 2025 Published 2025-08-20.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77941

Official notice

2025-08-20

The hazard

Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall. Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention. To date, there have been no reported complaints for this issue from customers for the product in scope. Recall start date: August 11, 2025

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

77941

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Affected products

Product 1

Affected products - Constellation Vision System Viscous Fluid Control Pak With EnGauge RFID, Lot or serial number - 17DPRT, Model or catalogue number - 8065-7509-57

Product 2

Affected products - Constellation Vision System Viscous Fluid Control Pak With EnGauge RFID, Lot or serial number - 17ERNK, Model or catalogue number - 8065-7509-57

Product 3

Affected products - Chandelier W/RFID, Lot or serial number - 17DPN7, Model or catalogue number - 8065751577

Product 4

Affected products - Chandelier W/RFID, Lot or serial number - 17DPN8, Model or catalogue number - 8065751577

Product 5

Affected products - Endoillumination Probes, Lot or serial number - 17E0TX, Model or catalogue number - 8065750972

Product 6

Affected products - Endoillumination Probes, Lot or serial number - 17C359, Model or catalogue number - 8065751441

Product 7

Affected products - Endoillumination Probes, Lot or serial number - 17C6U5, Model or catalogue number - 8065751441

Risk / hazard

Alcon is conducting this voluntary medical device field safety correction of impacted standalone vitrectomy consumables, as there is potential for some pouches within impacted lots to have an incomplete seal. While the incomplete seal is visibly noticeable within the pouch, due to the risk that the sterile barrier may be compromised, Alcon is conducting a recall. Should a non-sterile product be used during surgery, post-operative infection may result requiring medical and/or surgical intervention. To date, there have been no reported complaints for this issue from customers for the product in scope. Recall start date: August 11, 2025

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

Manufacturer

Not provided

Phone

Not provided

Brand: Alcon Laboratories, Alcon Vitrectomy.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77941

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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