EVA NEXUS Ophthalmic Surgical System— 510(k) K213467

Substantially Equivalent

D.O.R.C. Dutch Ophthalmic Research Center (International)

FDA 510(k) clearance K213467 for EVA NEXUS Ophthalmic Surgical System, Substantially Equivalent on 2022-06-14. Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International).

Clearance details

Applicant: D.O.R.C. Dutch Ophthalmic Research Center (International)
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2021-10-28
Decision date: 2022-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zuidland, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQC

product code HQC

Injury: 2,378
Malfunction: 8,768
Total: 11,146

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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