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Recall Observatory FDA recall evidence

Device product

TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

Z-2324-2026

April 30, 2026

Class II

Product summary

Firm
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Event
Event 98814
Status
Ongoing
Classification
Class II
Quantity
261 boxes totaling 1566 units
Official record key
device-enforcement:Z-2324-2026

Official wording

Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

Code information: 1. Article Number: 9268.VIT27; UDI-DI: 08717872031880; 2. Article Number: 9311.27G01; UDI-DI: 08717872035123; 3. Article Number: 9311.27G02; UDI-DI: 08717872035352; 4. Article Number: 9311.27K01; UDI-DI: N/A; 5. Article Number: 9311.27K02; UDI-DI: N/A; 6. Article Number: 9311.27K03; UDI-DI: N/A; 7. Article Number: 9627.G0101; UDI-DI: N/A; 8. Article Number: 9627.G0201; UDI-DI: N/A; 9. Article Number: 9311.27G01-00; UDI-DI: 08717872035321; Lot Numbers: 202511001, 202601070, 51682-*-*-1, 51683-*-*-1, 54025-*-*-1, 54995-*-*-1, 56258-*-*-1, 56259-*-*-1, 64307-*-*-1, 64310-*-*-1, 69018-*-*-1, 75718-*-*-1, 76781-*-*-1, 76810-*-*-1, 77842-*-*-1, 79461-*-*-1, 80339-*-*-1, 80964-*-*-1, 81336-*-*-1, 82214-*-*-1, 82743-*-*-1, 83585-*-*-1, 84581-*-*-1, 85452001, 86070001, 87206001, 90383001, 97231001;

Distribution pattern: Worldwide - US Nationwide and the countries of AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, CZECHIA, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, HONG KONG, IRELAND, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, POLAND, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, TURKEY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.