FDA Device Intelligence
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Knife, Ophthalmic

FDA product code HNN · Class 1 · Ophthalmic

3,154
Registered devices
7,502
Adverse events
155
Recalls
54
510(k) clearances

Devices with this code

Mastel Precision Surgical Instruments, Inc. — Mastel Surgical Inc.MSI Precision Specialty Instruments — Med Saver, Inc.MSI Precision Specialty Instruments — Med Saver, Inc.Ambler Surgical — AMBLER SURGICAL CORP.Ziplyft Device — Osheru, L.L.C.Oph.Knife — KATENA PRODUCTS, INC.Diamatrix — DiamatrixOphthalmic Knife — KATENA PRODUCTS, INC.Phaco Slit Knife 1.6 mm Bevel Up Angled with protection — AKTIVE SRLAmbler Surgical — AMBLER SURGICAL CORP.Unique Edge — Unique Technologies, Inc.MakEdge — MAKVIN SURGICAL LLCMANI Ophthalmic Knife — MANI, INC.Ophthalmic Knife — Medetz Surgical Instruments LLCAnodyne Surgical — Psi/Eye-Ko, Inc.Mastel Precision Surgical Instruments, Inc. — Mastel Surgical Inc.Mastel Precision Surgical Instruments, Inc. — Mastel Surgical Inc.MSI Precision Specialty Instruments — Med Saver, Inc.Rumex — RUMEX INTERNATIONAL CORP.Alcon — Alcon Laboratories, Inc.Stylus — Surgical Specialties México, S. de R.L. de C.V.Sklar — SKLAR CORPORATIONMANI Ophthalmic Knife — MANI, INC.Mastel Precision Surgical Instruments, Inc. — Mastel Surgical 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.