ClearCut Sideport Ophthalmic Knives Recalled Due to Sharpness Issues
Alcon has recalled ClearCut Sideport Knife ophthalmic surgical instruments due to an increase in complaint reports related to 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: This is a Class II recall of a surgical ophthalmic instrument, which is a risk-of-harm product. Although no injuries or illnesses are mentioned in the source, sharpness-related issues in a surgical knife could impact surgical precision and patient safety. Per the rubric, a risk-of-harm product without reported injuries scores as High (3).
Plain-English summary
Alcon Research LLC is recalling the ClearCut Sideport Knife Dual Bevel 1.2mm Angled, an ophthalmic surgical instrument (model 8065921541). The company has detected an increase in complaint reports related to sharpness for these devices.
The recall affects approximately 469,173 units distributed domestically throughout the United States and internationally to countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, and others. Healthcare facilities, surgical centers, and ophthalmologists using these instruments are affected.
Affected product is identified by specific lot numbers including 15W7XT, 15W7Y8, 15W7Y9, 15W9E6, 15W9E8, 15X5JJ, and others listed in official recall documentation. The device UDI-DI is 00380659215414. Healthcare providers should verify whether they have affected units.
The FDA is monitoring this Class II recall. Affected healthcare providers should contact Alcon for guidance regarding replacement or further instructions.
The recalled product
- Product
- Product Desc: Product Name: 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
- 469,173
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 numbers: 15W7XT
- 15W7Y8
- 15W7Y9
- 15W9E6
- 15W9E8
- 15X5JJ
- 15X56A
- 15X56C
- 15X5KV
- 15X5KX
- 1618UH
- 1618UJ
- 161A1K
- 1618V4
- 1618V5
- 161A21
- 161A22
- 162WY5
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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