Device product
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
Z-1954-2025
Product summary
- Firm
- Tecfen Medical
- Event
- Event 96872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42 units
- Official record key
device-enforcement:Z-1954-2025
Official wording
Reason: Sterility assurance for Ophthalmic knives.
Code information: Lot Code: Manufacture date: 2024-11-22 Expiration date: 2027-11-21 Lot number: ZGY24071501-03 UDI: 00817618021330
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.