FDA Medical Device Recalls (openFDA)
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.: 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;
- Recall number
- Z-2322-2026
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- 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;
- Status
- Open, Classified
- Initiated
- 2026-04-30
- Posted
- 2026-06-05
- Terminated
- not on file
- Reason
- An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
- Root cause
- Process design
- Action
- 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.
- Quantity
- 314 boxes, totaling 1884 units
- 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.
- Lot, serial or model codes
- 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;
- 510(k) numbers
- ["K213467"]
- PMA numbers
- not on file
- Product code
- HQE
- Firm FEI
- 3002806863
- Firm city
- Zuidland
- Firm state
- not on file
- Firm country
- Netherlands
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28