INFINITI VISION SYSTEM WITH OZIL IP— 510(k) K082845

Substantially Equivalent

Alcon Research, Ltd.

FDA 510(k) clearance K082845 for INFINITI VISION SYSTEM WITH OZIL IP, Substantially Equivalent on 2009-02-12. Applicant: Alcon Research, Ltd..

Clearance details

Applicant: Alcon Research, Ltd.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2008-09-26
Decision date: 2009-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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.