CONSTELLATION VISION SYSTEM— 510(k) K141065

Substantially Equivalent

Alcon Research, Ltd.

FDA 510(k) clearance K141065 for CONSTELLATION VISION SYSTEM, Substantially Equivalent on 2014-08-22. Applicant: Alcon Research, Ltd..

Clearance details

Applicant: Alcon Research, Ltd.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 2014-04-24
Decision date: 2014-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, CA, 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.