ClearCut®
ClearCut® S Safety Cresent Knife 2.3mm Angled Bevel Up
12manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Belle Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 20 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| 2nd Sight Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 1 |
| Shaanxi Xingmao Industry Co., Ltd. | Xi An | Shaanxi | Private-label distributor | 1 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HNN |
| Device type | Knife, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2020-08-18 |
| Record revised | 2026-03-02 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 6 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065993047 | In distribution | |
| 8065921540 | In distribution | |
| 8065771541 | In distribution | |
| 8065982665 | In distribution | |
| 8065771501 | In distribution | |
| 8065983265 | In distribution | |
| 8065921541 | In distribution | |
| 8065772745 | In distribution | |
| 8065992647 | In distribution | |
| 8065982865 | In distribution | |
| 8065773001 | In distribution | |
| 8065993245 | In distribution | |
| 8065992745 | In distribution | |
| 8065983065 | In distribution | |
| 8065771540 | In distribution | |
| 8065992747 | In distribution | |
| 8065993045 | In distribution | |
| 8065770002 | In distribution | |
| 8065992645 | Withdrawn | |
| 8065993048 | Withdrawn | |
| 8065995240 | Withdrawn | |
| 8065992848 | Withdrawn | |
| 8065921542 | Withdrawn | |
| 8065993540 | Withdrawn | |
| 8065992648 | Withdrawn | |
| 8065997048 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 283 |
| Mani Ophthalmic Knife | Mani, Inc. | 234 |
| Unique Edge | Unique Technologies, Inc. | 186 |
| Sharpoint | Surgical Specialties México, S. de R.L. de C.V. | 162 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 154 |
| Mastel Precision Surgical Instruments, Inc. | Mastel Surgical Inc. | 146 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 115 |
| Ophthalmic Knife | Ovation International | 81 |
| Ophthalmic Knife | Katena Products, Inc. | 72 |
| Premier Edge® Microsurgical Knives | Oasis Medical, Inc. | 69 |
| Micro Feather Disposable Ophthalmic Scalpel with plastic handle | Feather Safety Razor Co., Ltd. | 63 |
| ExactEtch | Diamatrix | 63 |
Showing 12 of 434. All products under Knife, Ophthalmic
Recalls Naming This Product
13 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 20,034 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 5,039 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 469,173 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 2,520 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 7,598 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 5,487 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 145,248 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 53,123 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 11,676 units |
| Alcon Research, LLC | UDI-DI | 2024-07-15 | Class II | Process control | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives. | 15,222 units |
| Alcon Research, LLC | UDI-DI | 2024-04-22 | Class II | 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. | 427,764 units |
| Alcon Research, LLC | UDI-DI | 2024-04-22 | Class II | 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. | 19,867 units |
| Alcon Research, LLC | UDI-DI | 2024-04-22 | Class II | 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. | 4,930 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.