Increased Complaints for Knife Sharpness Voluntary Field Safety Notice – ClearCute Dual Bevel 1.2mm Sideport, Clearcut Safety Dual Bevel 1.2mm Sideport, Clearcut Safety Dual Bevel 1.0mm Sideport and 20G MVR+ V-Lance Ophthalmic knives

Summary of the Medical Device User Manual

Alcon has issued a Voluntary Field Safety Notice regarding an increase in complaint reports related to the sharpness of certain ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.

The affected products include the CLEARCUT Dual Bevel 1.2mm Angled Sideport Knife, CLEARCUT Safety Dual Bevel 1.2mm Angled Sideport, CLEARCUT Safety Dual Bevel 1.0mm Angled Sideport, and 20 Gauge MVR+ Blade V-Lance.

If a knife does not meet expectations for sharpness, it may lead to increased penetration force during surgery, which can cause intraoperative complications such as corneal abrasion, Descemet’s detachment, or wound leakage.

Actions to be taken

If a knife does not perform as expected or if you feel it does not meet your expectation for sharpness, discontinue use of that specific knife and replace it with a new one to avoid potential complications.

The notice also provides information on how to report adverse events or product quality issues, and provides contact details for Alcon’s customer service and sales representatives.

Manual:

Download: Increased Complaints for Knife Sharpness Voluntary Field Safety Notice – ClearCute Dual Bevel 1.2mm Sideport, Clearcut Safety Dual Bevel 1.2mm Sideport, Clearcut Safety Dual Bevel 1.0mm Sideport and 20G MVR+ V-Lance Ophthalmic knives

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