Z-2322-2026Class II

TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02...

Name: Z-2322-2026 TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02...
Creator: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Published: 2026-04-30
License: https://open.fda.gov/license/

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. / initiated 2026-04-30 / Open, Classified / root cause: manufacturing process

FDA source

D.O.R.C. Dutch Opthalmic Research Center Intl B.V. began a recall of TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201... on 2026-04-30. FDA classified it as Class II and gives the reason as "An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2322-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-30
Posted: 2026-06-05
Recalling firm: D.O.R.C. Dutch Ophthalmic Research Center (International) 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;
Product code: HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Reason for recall: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2322-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2322-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2323-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05
Z-2324-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-05

Product code HQE

K213467Class IIEVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) / cleared 2022-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)