Device product
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
Z-1953-2025
Product summary
- Firm
- Tecfen Medical
- Event
- Event 96872
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 38 units
- Official record key
device-enforcement:Z-1953-2025
Official wording
Reason: Sterility assurance for Ophthalmic knives.
Code information: Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY23062808-02 UDI: 00817618021422
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.