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Alcon ophthalmic knife

Official notice

18 Aug 2024

Last checked

18 Aug 2024

Medium riskHealth Canada

An official Health Canada notice concerns Alcon ophthalmic knife. 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 Published 2024-08-18.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75495

Official notice

2024-08-18

The hazard

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

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

75495

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Affected products

Product 1

Affected products - ClearCut S Intrepid DB Safety Slit Knife, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065772465 8065772265

Product 2

Affected products - Valved Trocar Cannula Entry System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065751658

Product 3

Affected products - ClearCut S Intrepid SB Safety Slit Knife, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065772445 8065772245

Product 4

Affected products - Alcon Ophthalmic Crescent Knife, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065990002

Product 5

Affected products - ClearCut S Safety Slit Knife, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - 8065772745

Product 6

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

Risk / hazard

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

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, Alcon Ophthalmic Knife.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75495

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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