UNIT, PHACOFRAGMENTATION— 510(k) K103023

Substantially Equivalent

Abbott Medical Optics, Inc.

FDA 510(k) clearance K103023 for UNIT, PHACOFRAGMENTATION, Substantially Equivalent on 2011-06-01. Applicant: Abbott Medical Optics, Inc..

Clearance details

Applicant: Abbott Medical Optics, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2010-10-12
Decision date: 2011-06-01
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Santa Ana, CA, 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.