Recall Z-2323-2026— D.O.R.C. Dutch Opthalmic Research Center Intl B.V.

Name: FDA recall Z-2323-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-30

Class II · Ongoing

Class II FDA medical device recall by D.O.R.C. Dutch Opthalmic Research Center Intl B.V., initiated 2026-04-30. It names one FDA 510(k) clearance: K213467. Product: TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;. Reason: An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use..

Recalling firm: D.O.R.C. Dutch Opthalmic Research Center Intl B.V.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-30
Firm location: Zuidland, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K213467 — EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International)·cleared 2022-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.