Public recall detail

Custom-Pak Ophthalmic Surgery Procedure Pack

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Recall Safety notice
Quick summary

Quick summary: Custom-Pak Ophthalmic Surgery Procedure Pack.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Custom-Pak Ophthalmic Surgery Procedure Pack.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAlcon Laboratories Inc.
ProductCustom-Pak Ophthalmic Surgery Procedure Pack
IssueMedical devices - Performance
Recall classType II
IdentificationRA-73957

Affected products

ProductCustom-Pak Ophthalmic Surgery Procedure Pack
LotMore than 10 numbers, contact manufacturer.
Model00000-00 TO 99999-99
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCustom-Pak Ophthalmic Surgery Procedure Pack
ProductIntrepid Plus FMS Pack, Ultra Infusion Sleeve, Mini-Flared ABS Tip
LotMore than 10 numbers, contact manufacturer.
Model8065752087
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionIntrepid Plus FMS Pack, Ultra Infusion Sleeve, Mini-Flared ABS Tip
ProductCenturion Vision System - Active Irrigation FMS Pack, With Intrepid Ultra Sleeves
LotMore than 10 numbers, contact manufacturer.
Model8065752201 8065752200
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCenturion Vision System - Active Irrigation FMS Pack, With Intrepid Ultra Sleeves
ProductTurbosonics Tip
LotMore than 10 numbers, contact manufacturer.
Model8065-7900-22 8065-7508-53 8065-7408-37 8065752065 8065752066 8065-7900-20
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionTurbosonics Tip
ProductConstellation Vision System Fragmentation Pak
LotMore than 10 numbers, contact manufacturer.
Model8065-7509-58
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionConstellation Vision System Fragmentation Pak
ProductCenturion Vision System - Active Irrigation FMS Pack, Infusion Sleeves
LotMore than 10 numbers, contact manufacturer.
Model8065752918
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionCenturion Vision System - Active Irrigation FMS Pack, Infusion Sleeves

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - General hospital and personal use Health products - Medical devices - Ophthalmology
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-73957
Background{}
CompaniesAlcon Laboratories Inc. 6201 South Freeway, Fort Worth, Texas, United States, 76134-2099
AudiencesHealthcare
Source updated2023-07-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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