# K041998: Phaco Chop Needles

- Pathway: 510(k) (Special)
- Applicant: Bausch & Lomb, Inc.
- Decided: Aug 16, 2004 after 21 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Standard Phaco Needle: named in the summary without a submission number
- (no number) MicroFlow Phaco Needle: named in the summary without a submission number
- (no number) MicroFlow+ Phaco Needle: named in the summary without a submission number

## Most influential descendants
- K091777: Alcon Ultrachopper (2009), 20 descendants of its own
- K101285: Constellation Vision System (2010), 17 descendants of its own
- K112425: Infiniti Vision System Evergreen II Autosert Iol Injector Handpiece (2011), 8 descendants of its own
- K121555: Centurion Vision System (2012), 6 descendants of its own
- K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector) (2015), 5 descendants of its own

## Recalls of this device
- Jan 8, 2010 · Not classified · Z-1729-2010: 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-1728-2010: Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate
- Mar 26, 2008 · Not classified · Z-2051-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2046-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2044-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2049-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2052-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2045-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2047-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2048-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
- Mar 26, 2008 · Not classified · Z-2050-2008: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable

## Indications for use
The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protege or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.

Source page: https://510kreport.com/device/K041998
Methodology: https://510kreport.com/methodology