# K060366: The Amo Ophthalmic Surgical System

- Pathway: 510(k) (Abbreviated)
- Applicant: Advanced Medical Optics, Inc.
- Decided: Apr 7, 2006 after 53 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 K911808 (1991). 3 ancestors in all.
32 later devices descend from it; 6 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003638: Mojave Cataract Extraction System, Allergan, Inc. (2001) Summary page 1.
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 1.
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 1.

## Most influential descendants
- K063331: Bausch & Lomb NGX Microsurgical System (2006), 24 descendants of its own
- K082473: Bausch & Lomb Stellaris Microsurgical System (2009), 22 descendants of its own
- K101325: Stellaris PC Vision Enhancement System (2010), 14 descendants of its own
- K081877: Associate 2500 Dual and Compact Systems (2009), 8 descendants of its own
- K133486: Stellaris PC Vision Enhancement System (2014), 7 descendants of its own

## Recalls of this device
- Apr 2, 2008 · Not classified · Z-1702-2008: AMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification S

## Indications for use
The AMO Ophthalmic Surgical System is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The posterior segment surgery module is optional. The modular design allows the users to configure the system to meet their surgical requirements.

Source page: https://510kreport.com/device/K060366
Methodology: https://510kreport.com/methodology