Device product
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
Z-1949-2025
Product summary
- Firm
- Tecfen Medical
- Event
- Event 96872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1400
- Official record key
device-enforcement:Z-1949-2025
Official wording
Reason: Sterility assurance for Ophthalmic knives.
Code information: Lot Code: Manufacture date: 2024-11-25 Expiration date: 2027-11-24 Lot number: ZGY23100713-01 UDI: 00817618021286
Distribution pattern: Worldwide - US Nationwide distribution in the states of Connecticut and Minnesota. The countries of Dominican Republic, Saudi Arabia, Mexico, Chile, Iran, South Africa, Honduras, UAE, Honduras, Qatar, Iran, and Bangladesh, Brazil and Israel.
Derived failure modes
-
Unknown
Sterility assurance for Ophthalmic knives.