ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness
Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended during eye surgery.
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 Class II medical device recall involves a surgical instrument where decreased sharpness poses risk of patient harm if it affects surgical performance. Although no illnesses or injuries have been reported, it qualifies as a risk-of-harm product without reported injury per the severity rubric.
Plain-English summary
Alcon Research LLC is recalling specific batches of ClearCut S Safety Sideport Knife 1.0mm Dual Bevel ophthalmic surgical instruments (Model 8065771540). The recall affects approximately 20,034 units distributed nationwide in the United States and internationally.
Alcon has detected an increase in complaint reports related to sharpness of these ophthalmic knives. Instruments with decreased sharpness may not perform as intended during surgical eye procedures.
The affected units can be identified by model number 8065771540 and the following lot numbers: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, and 16DDRU.
Healthcare providers and surgical facilities using these instruments should contact Alcon directly regarding replacement, repair, or return of affected units.
The recalled product
- Product
- Product Name: 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
- Affected units
- 20,034
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 numbers: 1668D7
- 167PRA
- 167PTK
- 168NMF
- 169KL4
- 169KTP
- 16ALPE
- 16ALTU
- 16AV18
- 16DDPR
- 16DDRU
Distribution
Part of a larger recall action
This product is one of 36 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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