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Constellation® vision system total plus vitrectomy pak

Official notice

30 Jul 2025

Last checked

30 Jul 2025

Medium riskHealth Canada

An official Health Canada notice concerns Constellation® vision system total plus vitrectomy pak. On May 1, 2025 Alcon Canada was notified of market action due to damaged Tyvek® covers on specific lots of Alcon Constellation Pak®. Due to the risk of Constellation Pak® sterility being compromised, Alcon is correcting potentially affected lots. There is the potential that the Tyvek® cover of some units within specific lots of Alcon Constellation Pak® were damaged during the manufacturing process. This event was identified internally by Alcon. To date, no customer complaints or adverse events reported. Recall start date: May 6, 2025 Published 2025-07-30.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77779

Official notice

2025-07-30

The hazard

On May 1, 2025 Alcon Canada was notified of market action due to damaged Tyvek® covers on specific lots of Alcon Constellation Pak®. Due to the risk of Constellation Pak® sterility being compromised, Alcon is correcting potentially affected lots. There is the potential that the Tyvek® cover of some units within specific lots of Alcon Constellation Pak® were damaged during the manufacturing process. This event was identified internally by Alcon. To date, no customer complaints or adverse events reported. Recall start date: May 6, 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

77779

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Affected products

Product 1

Affected products - Constellation® Vision System Total Plus Vitrectomy Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065000093

Product 2

Affected products - Constellation® Vision System Total Plus Vitrectomy Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065752437

Product 3

Affected products - Constellation® Vision System Total Plus Vitrectomy Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065753109

Product 4

Affected products - Constellation® Vision System Total Plus Vitrectomy Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065752435

Product 5

Affected products - Constellation® Vision System Total Plus Vitrectomy Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065753106

Risk / hazard

On May 1, 2025 Alcon Canada was notified of market action due to damaged Tyvek® covers on specific lots of Alcon Constellation Pak®. Due to the risk of Constellation Pak® sterility being compromised, Alcon is correcting potentially affected lots. There is the potential that the Tyvek® cover of some units within specific lots of Alcon Constellation Pak® were damaged during the manufacturing process. This event was identified internally by Alcon. To date, no customer complaints or adverse events reported. Recall start date: May 6, 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

Brand: Alcon Laboratories, Constellation® Vision System Total Plus Vitrectomy Pak.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77779

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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