United StatesTDC VELOCE 23G, 25G and 27G Two Dimensional Cutters (20k CPM) are affected; affected article numbers include 9268.VIT23, 9311.23G01, 9311.23G02, 9268.VIT25, 9311.25G01, 9311.25G02, 9268.VIT27, 9311.27G01, 9311.27G02 and many related article/lot numbers listed in the notice. They were recalled because of an increase in complaints of a loose outer knife and reports of the outer knife becoming loose during use; the devices were distributed worldwide, including the United States.
What's being recalled
TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
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;
Recalling firm: D.O.R.C. Dutch Opthalmic Research Center Intl B.V., Zuidland, N/A, Netherlands.
How to identify it
1. Article Number: 9268.VIT23; UDI-DI: 08717872031866; 2. Article Number: 9311.23G01; UDI-DI: 08717872035109; 3. Article Number: 9311.23G02; UDI-DI: 08717872035338; 4. Article Number: 9311.23K01; UDI-DI: N/A; 5. Article Number: 9311.23K02; UDI-DI: N/A; 6. Article Number: 9311.23K03; UDI-DI: N/A; 7. Article Number: 9623.G0201; UDI-DI: N/A; 8. Article Number: 9623.G0202; UDI-DI: N/A; 9. Article Number: 9623.K0201; UDI-DI: N/A; 10. Article Number: 9311.23G01-00; UDI-DI: 08717872035307; Lot Numbers: 100637001, 57682-*-*-1, 64312-*-*-1, 69017-*-*-1, 73237-*-*-1, 74225-*-*-1, 75735-*-*-1, 79460-*-*-1, 80338-*-*-1, 80963-*-*-1, 81335-*-*-1, 81679-*-*-1, 82213-*-*-1, 82325-*-*-1, 82742-*-*-1, 82779-*-*-1, 83584-*-*-1, 84580-*-*-1, 85451001, 86069001, 86798001, 86799001, 87205001, 88231001, 91957001, 92629001, 92630001, 93336001, 94351001, 95436001, 95462001, 96097001, 96123001, 97279001, 97789001, 98643001, 99130001, 99185001, 99697001; 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…
The hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)