Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Health Canada has posted a medical device safety alert concerning Alcon Laboratories, Incorporated Alcon Ophthalmic Knife, Alcon Ophthalmic V-Lance Knife, Clearcut S Safety Sab Sideport Knife [Model or catalog number: 8065771541, 8065921541, 8065912001, 8065771540] [HKMD No.: 120360].
According to Health Canada, on April 24, 2024 the manufacturer 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.
For further information, please visit https://recalls-rappels.canada.ca/en/alert-recall/alcon-ophthalmic-knife
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 09 May 2024