# K063331: Bausch & Lomb NGX Microsurgical System

- Pathway: 510(k) (Abbreviated)
- Applicant: Bausch & Lomb, Inc.
- Decided: Dec 19, 2006 after 46 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K844373 (1985). 15 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961310: Storz  Premiere II Microsurgical System (CX Series), Storz Instrument Co. (1996) Summary page 2.
- K060366: The Amo Ophthalmic Surgical System, Advanced Medical Optics, Inc. (2006) Summary page 2.
- K952213: Alcon Series 20000 Legacy Phacoemulsifier, Alcon Laboratories (1995) Summary page 2.
- K021566: Infiniti, Alcon Laboratories, Inc. (2002) Summary page 2.

## Most influential descendants
- 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
- K121555: Centurion Vision System (2012), 6 descendants of its own

## Recalls of this device
- Jan 15, 2010 · Not classified · Z-1664-2010: The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.
- Jan 8, 2010 · Not classified · Z-1715-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1722-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1712-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1716-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1721-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1717-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1714-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1713-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1718-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1719-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Jan 8, 2010 · Not classified · Z-1720-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

## Indications for use
The Bausch & LombTM NGX Microsurgical System device is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, irrigation/aspiration, bipolar, coaxial, and bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Use only Bausch & Lomb disposable packs and handpieces designated for use with the system.

Source page: https://510kreport.com/device/K063331
Methodology: https://510kreport.com/methodology