Knife, Ophthalmic
Ophthalmic · 21 CFR 886.4350
Recent MDR events
7,502 adverse event reports on file
- ClearCut KnivesJul 31, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00796
- SLIT KNIFE 2.4MM ANGD SNGL BEV W/SAFETY (10/SP)Jul 31, 2026InjuryBeaver-visitec International, Inc.1211998-2026-00026
- ClearCut KnivesJul 31, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00797
- ClearCut Intrepid KnivesJul 31, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00798
- ClearCut KnivesJul 31, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00799
- ClearCut Intrepid KnivesJul 30, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00794
- V-LANCE KnivesJul 27, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00783
- ClearCut KnivesJul 27, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00784
- ClearCut Intrepid KnivesJul 27, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00786
- ClearCut Intrepid KnivesJul 27, 2026MalfunctionAlcon Research, Llc - Alcon Precision Device2523835-2026-00785
Event type breakdown
Most-reported manufacturers
Recalls
155 recall events for this product code
- SSC- Surgical Specialties CorporationOpen, ClassifiedJun 4, 2026
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
Z-2309-2026 · View FDA record ↗ - MicroSurgical Technology IncOpen, ClassifiedOct 29, 2025
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Z-0411-2026 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1949-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1950-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1951-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1952-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1953-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1954-2025 · View FDA record ↗ - Tecfen MedicalOpen, ClassifiedJun 11, 2025
Brand Name: Tecfen Medical
Sterility assurance for Ophthalmic knives.
Z-1955-2025 · View FDA record ↗ - Alcon Research LLCOpen, ClassifiedAug 16, 2024
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel
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.
Z-2645-2024 · View FDA record ↗
Registered firms
213 firms currently registered for this product code
Gsource, Llc.
EMERSON, NJ, US
Fujiiseiko Co., Ltd.
Kurate-machi Fukuoka, JP
Georg Alber Gmbh & Co. Kg
RENQUISHAUSEN Baden-Wurttemberg, DE
Teleflex Medical Llc
Morrisville, NC, US
Medetz Surgical Instruments
Jupiter, FL, US
Novo Surgical, Inc.
Westmont, IL, US
Feather Safety Razor Co., Ltd.
OSAKA, JP
Suqian Zhengtong Medical Instruments Co. Ltd
CHINA, HK
M/s Tarun Enterprises
Prayagraj, Uttar Pradesh, IN
Aspen Surgical Products, Inc.
Caledonia, MI, US
Core Surgical Limited
Thame Oxfordshire, GB
Beaver-visitec International, Inc.
Waltham, MA, US
Surgical Specialties Mexico S De Rl De Cv
Tijuana Baja California, MX
Choose Surgical Instruments
Sialkot Punjab, PK
Ultra Surgical (pvt.) Ltd
SIALKOT Punjab, PK
Bausch & Lomb Incorporated
Rochester, NY, US
Winfame Usa Inc.
Monrovia, CA, US
Harmac Medical Products, Inc./h3 De Tijuana, S. De Rl De C.v.
Tijuana Baja California, MX
Bis Mastermed
Kosice Kosicky, SK
Aurora Surgical, Llc
St Petersburg, FL, US
Hebumedical Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Walcott Rx Products, Inc.
Ocean View, NJ, US
Platinum Focus Group Ltd.
London London, City of, GB
Steris Corporation
Saint Louis, MO, US
Paramount Surgimed Ltd.
BHIWADI Rajasthan, IN
510(k) clearances
54 clearances for this product code
- Alcon Research, Ltd.May 20, 2011
K110166 · CLEARCUT S SAFETY KNIFE
- Microptics Development LaboratoryDec 10, 1992
K922378 · OPHTHALMIC KNIFE
- Optical CenterAug 22, 1988
K882402 · RETRACTIVE INCISION MICROMETER (RIM) GUAGE
- Advanced Surgical Products, Inc.May 13, 1988
K881669 · MVR/STILETTO BLADE 20GA. - P/N 1900
- Advanced Surgical Products, Inc.Apr 13, 1988
K874979 · PRISMA DISPOSABLE MVR/STILETTO BLADE
- Myocure, Inc.Dec 23, 1987
K874057 · OPHTHALMIC TIP & BLADE SCALPELS
- Myocure, Inc.Dec 22, 1987
K874056 · OPHTHALMIC DISPOSABLE BLADES
- Myocure, Inc.Sep 21, 1987
K873385 · OPHTHALMIC PHACO-BLADE