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Recall Observatory FDA recall evidence

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

April 25, 2025

Class II

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

    reason.no_named_rule · v1.0.0

    Sterility assurance for Ophthalmic knives.