| | Class 2 Device Recall TDC VELOCE |  |
| Date Initiated by Firm | April 30, 2026 |
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| Date Posted | June 05, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2322-2026 |
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| Recall Event ID |
98814 |
| 510(K)Number | K213467 |
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| Product Classification |
Instrument, vitreous aspiration and cutting, ac-powered - Product Code HQE
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| 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; |
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| Code Information |
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; |
| FEI Number |
3002806863
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Recalling Firm/
Manufacturer |
D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Scheijdelveweg 2
Zuidland Netherlands
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| For Additional Information Contact | IQVIA MedTech
1-585-471 6812 |
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Manufacturer Reason
for Recall | An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use. |
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FDA Determined
Cause 2 | Process design |
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| 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. |
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| Quantity in Commerce | 314 boxes, totaling 1884 units |
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| 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. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HQE
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