# K981168: Complete Brand Multi-Purpose Solution, Complete Brand Lubricating and Rewetting Drops

- Pathway: 510(k) (Traditional)
- Applicant: Allergan, Inc.
- Decided: Sep 1, 1998 after 153 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) COMPLETE® brand Multi-Purpose Solution: named in the summary without a submission number

## Recalls of this device
- Sep 15, 2006 · Not classified · Z-0346-2007: 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
COMPLETE® brand Multi-Purpose Solution is indicated for use in the chemical (NOT HEAT) disinfection, cleaning, rinsing, protein removal and storing of soft (hydrophilic) contact lenses as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K981168
Methodology: https://510kreport.com/methodology