D.O.R.C. Dutch Opthalmic Research Center Intl B.V. recalls TDC VELOCE"

An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.

TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27G02, 9311.27K01, 9311.27K02, 9311.27K03, 9627.G0101, 9627.G0201, 9311.27G01-00;

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.

• FDA enforcement recordOfficial FDA database entry for Z-2324-2026
• FDA 510(k) clearance · K213467The device's official FDA premarket clearance record
• FDA device classification · HQEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.4150The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find D.O.R.C. Dutch Opthalmic Research Center Intl B.V.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.