D.O.R.C. Dutch Opthalmic Research Center Intl B.V.: TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G01

Hazard

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

Details from the source

Reason for recall: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. Distribution: 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. Quantity: 261 boxes totaling 1566 units Lot/code info: 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;

UPC codes

08717872031880, 08717872035123, 08717872035352, 08717872035321

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.