510(k) · Cleared
Recalled · Class II · 2024Clearcut S Safety Knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · HNN Knife, Ophthalmic
Cleared on May 20, 2011 after a 120-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- May 20, 2011
- Review
- 120 days
- Class
- Class I
- Product code
- HNN
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HNN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | BD Beaver Safety Knife Named without a submission number | |
| * | — | KAI Safety Knife Named without a submission number | |
| * | — | Diamatrix ProTekt Safety Knife Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 22, 2024 | Class II | Z-1925-2024 | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. |
| Apr 22, 2024 | Class II | Z-1923-2024 | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. |
| Apr 22, 2024 | Class II | Z-1924-2024 | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. |
| Apr 22, 2024 | Class II | Z-1922-2024 | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All HNN devicesHNN Knife, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HNN
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · HNN
Too few HNN 510(k)s in any year since 2007 to give a median.
Recalls per year · HNN
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNN
690in 2025
MAUDE reports naming product code HNN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 36 | 21 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 13 |
| 2010 | 0 | — | 1 | 149 |
| 2011 | 1 | — | 0 | 223 |
| 2012 | 0 | — | 0 | 112 |
| 2013 | 0 | — | 0 | 173 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 401 |
| 2016 | 0 | — | 0 | 435 |
| 2017 | 0 | — | 44 | 472 |
| 2018 | 0 | — | 0 | 420 |
| 2019 | 0 | — | 0 | 291 |
| 2020 | 0 | — | 0 | 493 |
| 2021 | 0 | — | 1 | 403 |
| 2022 | 0 | — | 1 | 327 |
| 2023 | 0 | — | 2 | 355 |
| 2024 | 0 | — | 0 | 1,844 |
| 2025 | 0 | — | 1 | 690 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
ClearCut S Incisional Instruments are sterile, single-use disposable devices intended for use during ophthalmic surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110166: Clearcut S Safety Knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110166
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026