Health product recall

Alcon Ophthalmic Knife

Last updated

Summary

Product
Alcon Ophthalmic Knife
Issue
Medical devices - Device compatibility
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalog number

Alcon Ophthalmic Slit Knife

More than 10 numbers, contact manufacturer.

8065992561
8065993047
8065992747
8065992647
8065911901
8065992761

Alcon Ophthalmic Slit Knife, ClearCut

More than 10 numbers, contact manufacturer.

8065992445
8065992745
8065983065
8065993045
8065983265
8065992245
8065982465

ClearCut S Intrepid DB Safety Slit Knife

More than 10 numbers, contact manufacturer.

8065772465
8065772265

Valved Trocar Cannula Entry System

More than 10 numbers, contact manufacturer.

8065751658

ClearCut S Intrepid SB Safety Slit Knife

More than 10 numbers, contact manufacturer.

8065772445
8065772245

Alcon Ophthalmic Crescent Knife

More than 10 numbers, contact manufacturer.

8065990002

ClearCut S Safety Slit Knife

More than 10 numbers, contact manufacturer.

8065772745

Constellation Vision System Total Plus Vitrectomy Pak

More than 10 numbers, contact manufacturer.

8065000093
8065752438
8065000095
8065752437
8065751618
8065830077
8065753106
8065751617

Custom-Pak Ophthalmic Surgery Procedure Pack

More than 10 numbers, contact manufacturer.

00000-00 TO 99999-99

Constellation System, Total Plus Combined Procedure Pak

More than 10 numbers, contact manufacturer.

8065752451
8065752450
8065751767

Issue

On April 24, 2024 Alcon Canada was notified of an increase in customer reports of dull or knife not sharp for specific ClearCut® Dual Bevel Sideport and A-OK® Corneal/Scleral V-lance ophthalmic knives. Knives that do not meet customer sharpness expectations could result in the use of increased penetration force during surgery when compared to a sharper knife.

The initial scope was based on an observed in-process data shift for a specific knife family. Based on the new complaint signal, out of an abundance of caution, Alcon is now including all blades, of all models, made August 1, 2023 to March 2, 2024. 

Recall start date: April 26, 2024

Additional information

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

Alcon Laboratories Inc.

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

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-75495

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