TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
Recall
- Recall Number
- Z-2323-2026
- Event Number
- 98814
- Firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Scheijdelveweg 2 Zuidland Netherlands
- FEI Number
- 3002806863
- Product Code
- HQE
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- April 30, 2026
- Posted
- June 5, 2026
Description
TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
On April 30, 2026 Urgent Medical Device Recall letters were sent to customers. Actions to be taken: Review this Product information as soon as possible with relevant members of your staff. 1. Pass this FSN as soon as possible on to all those who need to be aware of it, including other locations, organizations and/or customers who might have received the impacted Product(s) through you. 2. If you have the affected Products and the affected lots (see attachment below) in your inventory, remove and return them to DORC following the instructions in the attachment. 3. Follow the instructions on how to complete and submit the Field Action Acknowledgement Form that is provided with this FSN.
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.
2068 boxes totaling 12408 units