TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311
FDA device recall Z-2324-2026 · posted 2026-06-05 · Open, Classified
Recall details
- Recalling firm
- D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
- Reason for recall
- An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- HQE
- Quantity affected
- 261 boxes totaling 1566 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, POLA
- Date initiated
- 2026-04-30
- Date posted
- 2026-06-05
- Location
- Zuidland, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVA NEXUS Ophthalmic Surgical System (K213467) | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022-06-14 |