# K033941: Millennium Microsurgical System and Peristaltic Phaco Pack

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Feb 10, 2004 after 53 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- 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: 2 generations back to K844373 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 2.
- K981116: Sovereign Cataract Extraction System, Allergan, Inc. (1998) Summary page 2.
- (no number) Millennium Microsurgical System: named in the summary without a submission number
- (no number) Millennium Concentrix Module: named in the summary without a submission number
- (no number) Millennium Venturi Module: named in the summary without a submission number

## Recalls of this device
- Jan 8, 2010 · Not classified · Z-1710-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

## Indications for use
Millennium Peristaltic Pump System The Bausch & Lomb (B&L) Millennium Peristaltic Pump System is intended for the introduction of Balanced Salt Solution (BSS) into the eye, as well as, the aspiration of fluid/tissue from the eye during ophthalmic anterior surgery. The Millennium Peristaltic Pump System consists of the B&L CX4100 module to be used with the B&L Millennium Microsurgical System and the B&L Peristaltic Phaco Pack, CX5310 sterile single-use accessory pack which consists of the various components/accessories necessary to enable the use of B&L Anterior Handpieces with the Millennium Microsurgical System.

Source page: https://510kreport.com/device/K033941
Methodology: https://510kreport.com/methodology