Clearcut S Safety Knife

by Alcon Research, Ltd.

510(k) K110166

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K110166↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Abbreviated	NumberK110166	Date20 May 2011Cleared	StatusActive

Recalls

4 recalls · 4 ongoing · FDA

4 recalls, same reason
- Ongoing Z-1922-2024 FDA Class II initiated 22 Apr 2024
- Ongoing Z-1924-2024 FDA Class II initiated 22 Apr 2024
- Ongoing Z-1923-2024 FDA Class II initiated 22 Apr 2024
- Ongoing Z-1925-2024 FDA Class II initiated 22 Apr 2024
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.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K110166
FDA Product Code: HNN

Device Class: Class I
Regulation: 21 CFR Part 886.4350
Advisory Committee: Ophthalmic
FDA Decision: SESE Substantially Equivalent

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