# K020527: Horizon Phacoemulsification System, Model HZN-2030

- Pathway: 510(k) (Traditional)
- Applicant: American Optisurgical, Inc.
- Decided: Jul 9, 2002 after 140 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K931354 (1994). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931354: P4000 Phacoemulsifier, American Optical Corp. (1994) Summary page 1.
- K991852: Ocusystem Art Advantage, Model 995, Surgical Design Corp. (1999) Summary page 1.
- K946054: Diplomax, Optical Micro Systems, Inc. (1995) Summary page 1.

## Most influential descendants
- K080803: Visual Phacoemulsification System, Model 551 (2008), 0 descendants of its own

## Recalls of this device
- Mar 24, 2009 · Not classified · Z-1808-2009: Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay

## Indications for use
The Horizon Phacoemulsification System performs phacofragmentation/ phacoemulsification with ultrasonic energy to disrupt and extract cataractous lens material from the eye.

Source page: https://510kreport.com/device/K020527
Methodology: https://510kreport.com/methodology