Knife, Ophthalmic
FDA adverse event reports and recall history for knife, ophthalmic (product code HNN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,417
- Deaths
- 0
- Injuries
- 353
- Malfunctions
- 7,043
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-06-04Open, ClassifiedMixed-up of materials/components
Sharpoint 2.2MM, ANGLED, DOUBLE- BEVEL Model/Catalog Number: 72-2231 Microsurgical Knife
3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.
- 2025-10-29Open, ClassifiedMaterial/Component Contamination
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
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives are used to make precise and fluid tight incisions during eye surgeries such as cataract procedures, vitreoretinal surgery, glaucoma surgery, corneal surgery, and oculoplastic procedures. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number: QKN2461 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number: QKN2808 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife Straight Model/Catalog Number: QKN2312 Software Version: No software Product Description: This is an ophthalmic knife (manual( that is to be sterile and packaged individually in Tyvek 1059B. MVR sideport knives are used to create precision incisions in vitrectomy procedures. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create smooth, curved incisions for corneal transplant procedures, used in small incision cataract surgery and phacoemulsification to create self-sealing scleral tunnels, used for creating tunnel incisions in the sclera and cornea during procedures like trabeculectomy. Component: No
Sterility assurance for Ophthalmic knives.
- 2025-06-11Open, ClassifiedUnder Investigation by firm
Brand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number: QKN3261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyvek 1059B. Slit knives are used to create precise incisions for controlled entry into the eye. Component: No
Sterility assurance for Ophthalmic knives.
- 2024-08-16Open, ClassifiedProcess control
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
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.
Monitor knife, ophthalmic automatically
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