D.o.r.c. Dutch Opthalmic Research Center Intl B.v. Scheijdelveweg 2 Zuidland Netherlands: Instrument, Vitreous Aspiration And Cutting, Ac-powered
D.O.R.C. is recalling certain TDC VELOCE vitreous cutters used in eye surgery because the outer knife can become loose during use. The affected devices are identified by specific article numbers and were distributed worldwide, including throughout the United States and multiple other countries. This is a Class II recall, meaning the product could cause serious health problems but is unlikely to cause death.
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands
- 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;
- 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/d1fbcf3f-2234-4e1f-8d17-c27df6d4dae5