# K014202: Complete Brand Multi-Purpose Solution

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Feb 20, 2002 after 61 days
- Product code: LPN (Accessories, Soft Lens Products)
- 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: 1 generation back to K003252 (2001). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003252: Complete Brand Multi-Purpose Solution, Allergan, Inc. (2001) Summary page 1.
- K013479: Complete Brand Multi-Purpose Solution, Allergan, Inc. (2002). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K202932: ABT12 multi-purpose solution (2021), 0 descendants of its own

## Recalls of this device
- Jul 23, 2010 · Not classified · Z-0129-2011: The recall was initiated after AMO determined, through internal testing, that a limited number of the flip top caps used during production of these solutions may leak and, although unlikely, the steri
- Sep 15, 2006 · Not classified · Z-0345-2007: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue a

## Indications for use
TRADE NAME Multi-Purpose Solution is indicated for the care of soft (hydrophilic) contact lenses. Use this product, as recommended by your eye care practitioner, to: Chemically (NOT HEAT) Disinfect Clean Rinse Store Remove Protein

Source page: https://510kreport.com/device/K014202
Methodology: https://510kreport.com/methodology