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Custom-pak ophthalmic surgery procedure pack

Official notice

14 Jul 2023

Last checked

14 Jul 2023

Medium riskHealth Canada

An official Health Canada notice concerns Custom-pak ophthalmic surgery procedure pack. Alcon Canada Inc. Will be initiating a voluntary medical device recall (advisory) on specific catalog numbers of Alcon Phaco tips & packs containing those Phaco tips. There is a potential for the Phaco tip wrench to generate plastic particles if the Phaco tip is over-tightened to the handpiece. The purpose of the advisory notice is to provide customer guidance when tightening the Phaco tip to mitigate the risk of generating plastic particles that have potential to enter the eye during surgery. Recall start date: June 30, 2023 Published 2023-07-14.

What to do now

Contact the manufacturer if you require additional information.

Recall number

73957

Official notice

2023-07-14

The hazard

Alcon Canada Inc. Will be initiating a voluntary medical device recall (advisory) on specific catalog numbers of Alcon Phaco tips & packs containing those Phaco tips. There is a potential for the Phaco tip wrench to generate plastic particles if the Phaco tip is over-tightened to the handpiece. The purpose of the advisory notice is to provide customer guidance when tightening the Phaco tip to mitigate the risk of generating plastic particles that have potential to enter the eye during surgery. Recall start date: June 30, 2023

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

73957

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Affected products

Product 1

Affected products - Custom-Pak Ophthalmic Surgery Procedure Pack, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 00000-00 TO 99999-99

Product 2

Affected products - Constellation Vision System Fragmentation Pak, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065-7509-58

Risk / hazard

Alcon Canada Inc. Will be initiating a voluntary medical device recall (advisory) on specific catalog numbers of Alcon Phaco tips & packs containing those Phaco tips. There is a potential for the Phaco tip wrench to generate plastic particles if the Phaco tip is over-tightened to the handpiece. The purpose of the advisory notice is to provide customer guidance when tightening the Phaco tip to mitigate the risk of generating plastic particles that have potential to enter the eye during surgery. Recall start date: June 30, 2023

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, Custom-pak Ophthalmic Surgery Procedure Pack.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

73957

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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