D.o.r.c. Dutch Opthalmic Research Center Intl B.v. Scheijdelveweg 2 Zuidland Netherlands: Instrument, Vitreous Aspiration And Cutting, Ac-powered
Recall Summary D.O.R.C. is recalling TDC VELOCE vitreous aspiration and cutting instruments used in eye surgery because the outer knife can become loose during use. The affected devices were distributed worldwide, including throughout the United States and multiple countries. This is a Class II recall, meaning the product could cause serious health problems or failure but is not likely to cause death.
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands
- Product
- 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;
- Reason
- An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-30
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e9940115-ae13-4724-b4e4-441e73b729f3