510(k) K213467 ยท HQC Unit, Phacofragmentation
EVA NEXUS Ophthalmic Surgical System
| Applicant | D.O.R.C. Dutch Ophthalmic Research Center (International), Zuidland, NL |
| Decision | Substantially Equivalent, Jun 14, 2022 |
| Received | Oct 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213467
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. 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; Open, Classified |
HQE | None listed |
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM;
Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201; Open, Classified |
HQE | None listed |
| Jun 5, 2026 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. 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; Open, Classified |
HQE | None listed |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (23 gauge / 0.6 mm) Open, Classified |
HQC | None listed |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (25 gauge / 0.5 mm) Open, Classified |
HQC | None listed |
| Mar 21, 2024 | D.O.R.C. Dutch Opthalmic Research Center Intl B.V. Directional Laser Probe with Alcon / Lumenis connector (27 gauge / 0.4 mm) Open, Classified |
HQC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.