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Knife, Ophthalmic

FDA product code HNN · Class 1 · Ophthalmic

3,166
Registered devices
7,592
Adverse events
155
Recalls
54
510(k) clearances

Devices with this code

1mm Paracentesis Blade, Diamond — KATALYST SURGICAL LLCMastel Precision Surgical Instruments, Inc. — Mastel Surgical Inc.Premier Edge® Microsurgical Knives — OASIS MEDICAL, INC.Anodyne Surgical — Psi/Eye-Ko, Inc.Pro-Paks — MICROSPECIALITIES, INC.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONUNICAT 10 FACET (MULTI-INCISION) DK 1MM — KATENA PRODUCTS, INC.Ophthalmic Knife — KATENA PRODUCTS, INC.Wexler Surgical, Inc. — WEXLER SURGICAL, INC.Diamatrix — DiamatrixSharpoint — Surgical Specialties México, S. de R.L. de C.V.Unique Edge — Unique Technologies, Inc.Integra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONSharpoint — Surgical Specialties México, S. de R.L. de C.V.Crescent Knife 2.0 mm Bevel Up Straight with protection — AKTIVE SRLExactEtch — DiamatrixBLADE BREAKERS AND HOLDERS — AURORA SURGICAL, LLCMICRO FEATHER SAFESHIELD DISPOSABLE OPHTHALMIC SCALPEL — FEATHER SAFETY RAZOR CO., LTD.Diamatrix Ltd. — DiamatrixPAUFIQUE GRAFT KNIFE — KATENA PRODUCTS, INC.Unique Edge — Unique Technologies, Inc.Ambler Surgical — AMBLER SURGICAL CORP.MICRO FEATHER OPHTHALMIC SCALPEL with aluminum handle — FEATHER SAFETY RAZOR CO., LTD.Anodyne Surgical — Psi/Eye-Ko, Inc.

Recent recalls

DateFirmReason
2026-04-23SSC- Surgical Specialties Corporation3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
2025-08-20MicroSurgical Technology IncAn ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cau
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2025-04-25Tecfen MedicalSterility assurance for Ophthalmic knives.
2024-07-15Alcon Research LLCAlcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic kn

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.