AMERICAN MEDICAL OPTICS I/A KIT- IRRIG— 510(k) K842197

Substantially Equivalent

American Medical Optics

FDA 510(k) clearance K842197 for AMERICAN MEDICAL OPTICS I/A KIT- IRRIG, Substantially Equivalent on 1984-10-01. Applicant: American Medical Optics.

Clearance details

Applicant: American Medical Optics
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1984-06-04
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.