# K033653: Venturi Phaco Pack

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Dec 17, 2003 after 26 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K882240 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955901: Storz DP4310DELUXE Phaco Pack Without Reflux, Storz Instrument Co. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K955901, K952259: DP4330. Number could not be read

## Recalls of this device
- Jan 8, 2010 · Not classified · Z-1709-2010: 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-1708-2010: 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-1711-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

## Indications for use
The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegd or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.

Source page: https://510kreport.com/device/K033653
Methodology: https://510kreport.com/methodology