# K083757: BPZ02 Multipurpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Nov 18, 2009 after 336 days
- Product code: LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K021635 (2002). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033608: Aquify Multi-Purpose Solution, Ciba Vision Corporation (2004) Summary page 1.
- K050729: Alcon Multi-Purpose Disinfecting Solution, Alcon Research, Ltd. (2005) Summary page 1.

## Most influential descendants
- K210051: OTE MPS 045 Multi-purpose Lens Care Solution (2021), 0 descendants of its own
- K102860: Alcon Multi-Pirpose Disinfecting Solution (2011), 0 descendants of its own

## Recalls of this device
- Sep 25, 2014 · Class II · Z-0126-2015: Product lot did not meet the specification for its disinfectants at the time of manufacture.
- Apr 21, 2014 · Class II · Z-1554-2014: Out of specification results for one of the two disinfectants.

## Indications for use
Bausch & Lomb® BPZ02 MultiPurpose Solution is indicated for use in the daily conditioning, cleaning, removal of protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K083757
Methodology: https://510kreport.com/methodology