510(k) K112425— INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE

Substantially Equivalent

Alcon Manufacturing, Ltd.

Clearance details

Applicant: Alcon Manufacturing, Ltd.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2011-08-23
Decision date: 2011-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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.