Alcon ClearCut S and A-OK ophthalmic surgical knives recalled for sharpness defects
Alcon is recalling about 19,867 ClearCut S and A-OK ophthalmic surgical knives worldwide due to an increase in complaints about blade sharpness.
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: FDA Class II medical device with a reported quality defect. Improper blade sharpness in ophthalmic surgical instruments poses a risk of surgical complications; however, no patient injuries have been reported to date, placing this as a risk-of-harm situation without reported harm.
Plain-English summary
Alcon Research LLC is recalling approximately 19,867 ClearCut S Safety Sideport Knife and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives worldwide. The affected instruments have been distributed across the United States and over 40 additional countries.
The manufacturer detected an increase in complaint reports related to blade sharpness for these surgical knives. Improper sharpness may complicate ophthalmic procedures, though no patient injuries have been reported to date.
The affected products have been distributed both as standalone sterile instruments and as components in Alcon Custom Pak surgical kits. While standalone knives have been placed on hold, Custom Pak kits continue limited distribution to prevent immediate market shortages and surgical delays.
Surgeons and surgical centers should verify they do not have affected products and contact Alcon for replacement or additional information about the recall.
The recalled product
- Product
- ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 19,867
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 (13)
- Model/Catalog Number: 8065771540
- UDI/DI: 00380657715404
- Lot/Batch: 1668D7
- 167PRA
- 167PTK
- 168NMF
- 169KL4
- 169KTP
- 16ALPE
- 16ALTU
- 16AV18
- 16DDPR
- 16DDRU
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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