ClearCut and A-OK ophthalmic surgical knives recalled for sharpness issues
Alcon is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to increased complaint reports about sharpness. Approximately 427,764 units are affected 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: Per the rubric, this is a High severity recall because it involves risk-of-harm products (surgical instruments) where injury has not yet been reported. The recall is FDA Class II with identified quality complaints about sharpness.
Plain-English summary
Alcon Research LLC is recalling ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic surgical knives due to an increase in complaint reports related to sharpness.
Approximately 427,764 units of the affected products have been distributed worldwide. Specific lot numbers have been identified in the recall documentation. Stand-alone sterile knives have been placed on hold, while knives included in Alcon Custom Pak surgical procedure packs continue to be distributed to prevent immediate market shortages.
Healthcare providers and surgical facilities that have received affected products should contact Alcon Research LLC with questions about the sharpness issue and to determine appropriate management of their inventory.
The recalled product
- Product
- ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
- Manufacturer
- Alcon Research LLC
- Hazard
- Affected units
- 427,764
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 (20)
- Model/Catalog Number: 8065921541
- UDI/DI: 00380659215414
- Lot/Batch: 15W7XT
- 15W7Y8
- 15W7Y9
- 15W9E6
- 15W9E8
- 15X5JJ
- 15X56A
- 15X56C
- 15X5KV
- 15X5KX
- 1618UH
- 1618UJ
- 161A1K
- 1618V4
- 1618V5
- 161A21
- 161A22
- 162WY5
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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