Ophthalmic surgical knives recalled due to sharpness complaints
Alcon is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel) due to increased reports of sharpness issues. The recall affects 4,930 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving surgical instruments where the identified hazard (loss of sharpness) could impact surgical precision. No hospitalizations, serious injuries, or deaths have been reported, placing this in the 'High' category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Alcon Research LLC is recalling the ClearCut S Safety Sideport Knife 1.2mm Dual Bevel (Model 8065771541) ophthalmic surgical knife. This precision instrument is used in eye surgery.
The recall was initiated due to an increase in complaint reports regarding the sharpness of these surgical knives. Approximately 4,930 units have been affected and distributed worldwide, including the United States and over 40 countries.
Standalone sterile knives have been placed on hold. However, knives included in Alcon Custom Pak surgical procedure packs are continuing to be distributed, as Alcon determined that halting distribution would create an immediate market shortage and result in canceled surgeries.
Healthcare providers and facilities that received affected units should be aware of the sharpness concerns when using these knives. For more information about the recall, contact Alcon or refer to FDA recall number Z-1925-2024.
The recalled product
- Product
- ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 4,930
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model/Catalog Number: 8065771541
- UDI/DI: 00380657715411
- Lot/Batch: 168NME
- 168NND
- 16AV17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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