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Recall Observatory FDA recall evidence

Device product

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

Z-1951-2025

April 25, 2025

Class II

Product summary

Firm
Tecfen Medical
Event
Event 96872
Status
Ongoing
Classification
Class II
Quantity
115 unit
Official record key
device-enforcement:Z-1951-2025

Official wording

Reason: Sterility assurance for Ophthalmic knives.

Code information: Lot Code: Manufacture date: 2024-11-21 Expiration date: 2027-11-20 Lot number: ZGY24081907-02 UDI: 00817618021156

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

    reason.no_named_rule · v1.0.0

    Sterility assurance for Ophthalmic knives.