Health product recall

Custom-Pak Ophthalmic Surgery Procedure Pack

Last updated

Summary

Product
Custom-Pak Ophthalmic Surgery Procedure Pack
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Custom-Pak Ophthalmic Surgery Procedure Pack

More than 10 numbers, contact manufacturer.

00000-00 TO 99999-99

Intrepid Plus FMS Pack, Ultra Infusion Sleeve, Mini-Flared ABS Tip

More than 10 numbers, contact manufacturer.

8065752087

Centurion Vision System - Active Irrigation FMS Pack, With Intrepid Ultra Sleeves

More than 10 numbers, contact manufacturer.

8065752201
8065752200

Turbosonics Tip

More than 10 numbers, contact manufacturer.

8065-7900-22
8065-7508-53
8065-7408-37
8065752065
8065752066
8065-7900-20

Constellation Vision System Fragmentation Pak

More than 10 numbers, contact manufacturer.

8065-7509-58

Centurion Vision System - Active Irrigation FMS Pack, Infusion Sleeves

More than 10 numbers, contact manufacturer.

8065752918

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Health products - Medical devices - Ophthalmology
Companies

Alcon Laboratories Inc.

6201 South Freeway, Fort Worth, Texas, United States, 76134-2099

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73957

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