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Nanocut

AUROLAB · Model S15002 · UDI-DI 10803878036341

HNN
10
510(k) clearances
7,592
Adverse events
155
Recalls
206
Facilities

Description

Nanocut Ophthalmic Surgical blades are an ophthalmic medical device and it is made from stainless steel grade 7C27Mo2.

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 cause eye irritation
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 knives.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.