Device product
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
Z-1955-2025
Product summary
- Firm
- Tecfen Medical
- Event
- Event 96872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-1955-2025
Official wording
Reason: Sterility assurance for Ophthalmic knives.
Code information: Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24022804-05 UDI: 00817618021224
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.