AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE— 510(k) K941603

Substantially Equivalent

Allergan Medical Optics

FDA 510(k) clearance K941603 for AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE, Substantially Equivalent on 1994-07-06. Applicant: Allergan Medical Optics.

Clearance details

Applicant: Allergan Medical Optics
Product code: Code KYB
Advisory panel: Ophthalmic
Date received: 1994-04-01
Decision date: 1994-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KYB

product code KYB

Injury: 218
Malfunction: 1,989
Other: 1
Total: 2,208

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.