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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