D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM— 510(k) K010082

Substantially Equivalent

Dutch Ophthalmic USA, Inc.

FDA 510(k) clearance K010082 for D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM, Substantially Equivalent on 2001-03-12. Applicant: Dutch Ophthalmic USA, Inc..

Clearance details

Applicant: Dutch Ophthalmic USA, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 2001-01-10
Decision date: 2001-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kingston, NH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.