THE AMO OPHTHALMIC SURGICAL SYSTEM— 510(k) K060366

Substantially Equivalent

Advanced Medical Optics, Inc.

FDA 510(k) clearance K060366 for THE AMO OPHTHALMIC SURGICAL SYSTEM, Substantially Equivalent on 2006-04-07. Applicant: Advanced Medical Optics, Inc..

Clearance details

Applicant: Advanced Medical Optics, Inc.
Product code: Code HQC
Advisory panel: Ophthalmic
Date received: 2006-02-13
Decision date: 2006-04-07
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.