Recall
FDAHealthApril 30, 2026

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. — TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 30, 2026

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.

What's affected?

Product
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Lot code
101118001

Additional details

1. Article Number: 9268.VIT25; UDI-DI: 08717872031873; 2. Article Number: 9311.25G01; UDI-DI: 08717872035116; 3. Article Number: 9311.25G02; UDI-DI: 08717872035345; 4. Article Number: 9311.25K01; UDI-DI: N/A; 5. Article Number: 9311.25K02; UDI-DI: N/A; 6. Article Number: 9311.25K03; UDI-DI: N/A; 7. Article Number: 9625.G0201; UDI-DI: N/A; Lot Numbers: 101118001, 101799001, 101800001, 102675001, 102676001, 103507001, 103508001, 103509001, 104360001, 50489-*-*-1, 54992-*-*-1, 54993-*-*-1, 54994-*-*-1, 56251-*-*-1, 56254-*-*-1, 56255-*-*-1, 56256-*-*-1, 56257-*-*-1, 57683-*-*-1, 58588-*-*-1, 58589-*-*-1, 60300-*-*-1, 65315-*-*-1, 65316-*-*-1, 65317-*-*-1, 65318-*-*-1, 65319-*-*-1, 65320-*-*-1, 65321-*-*-1, 65322-*-*-1, 66818-*-*-1, 70551-*-*-1, 70552-*-*-1, 70565-*-*-1, 70566-*-*-1, 70567-*-*-1, 71803-*-*-1, 71804-*-*-1, 71805-*-*-1, 71806-*-*-1, 75717-*-*-1, 76191-*-*-1, 76516-*-*-1, 76806-*-*-1, 76807-*-*-1, 76808-*-*-1, 76852-*-*-1, 76853-*-*-1, 76854-*-*-1, 76855-*-*-1, 77374-*-*-1, 77375-*-*-1, 77501-*-*-1, 77502-*-*-1, 77503-*-*-1, 77504-*-*-1, 77505-*-*-1, 78097-*-*-1, 78098-*-*-1, 78110-*-*-1, 78111-*-*-1, 79425-*-*-1, 79426-*-*-1, 81292-*-*-1, 81293-*-*-1, 81681-*-*-1, 82172-*-*-1, 82173-*-*-1, 82174-*-*-1, 82326-*-*-1, 82702-*-*-1, 82703-*-*-1, 82704-*-*-1, 82778-*-*-1, 83543-*-*-1, 83544-*-*-1, 84535-*-*-1, 84536-*-*-1, 84537-*-*-1, 85411001, 85412001, 86024001, 86025001, 86026001, 86806001, 86807001, 87173001, 87174001, 87175001, 87390001, 87950001, 88204001, 88205001, 88552001, 88616001, 89535001, 90377001, 90378001, 90379001, 91280001, 91281001, 92631001, 92633001, 95437001, 99667001;

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2068 boxes totaling 12408 units.

View original FDA notice →

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