# K021143: Opti-Free Express Multi-Purpose Disinfecting Solution

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Universal, Ltd.
- Decided: Aug 8, 2002 after 121 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
Longest line of descent: 1 generation back to K974624 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973332: Alcon Multi-Purpose Disinfecting Solution ID 90746, Alcon Laboratories (1997) Summary page 2.
- K974624: Alcon Multi-Purpose Disinfecting Solution ID 90746, Alcon Laboratories (1998) Summary page 2.
- K983780: Multi-Purpose Disinfecting Solution ID 90746, Alcon Laboratories (1998) Summary page 2.
- K001214: Opti-Free Express Multi-Purpose Disinfecting Solution, Alcon Universal, Ltd. (2000)
- K002589: Opti-Free Express Multi-Purpose Disinfecting Solution, Alcon Universal, Ltd. (2000)

## Recalls of this device
- Jun 23, 2022 · Class II · Z-1540-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

## Indications for use
For use in the daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) as recommended by your eye care practitioner. OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution can also be used as a diluent for OPTI-FREE SUPRACLENS Daily Protein Remover.

Source page: https://510kreport.com/device/K021143
Methodology: https://510kreport.com/methodology