# K992028: Refresh Contacts Lubricating and Rewetting Drops

- Pathway: 510(k) (Abbreviated)
- Applicant: Allergan, Inc.
- Decided: Oct 7, 1999 after 113 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 P910075/S007 (1996). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960012: Refresh CL (TM)/Lubricating and Reweting Drops, Abbott Medical Optics, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P960012/S001 (Apr 24, 1997). Summary page 3.
- P910075/S007: Complete Brand Lubricating and Rewetting Drops, Advanced Medical Optics, Inc. (1996). A supplement to the PMA, as the summary prints it.
- P900047: Wet-N-Soak (TM) Rewetting Drops, Advanced Medical Optics, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P900047/S002 (Apr 5, 1994). Summary page 3.

## Most influential descendants
- K083812: Refresh Optive Lens Comfort Rewetting Drops (2009), 1 descendant of its own
- K190674: REFRESH RELIEVA For CONTACTS (2019), 0 descendants of its own
- K032481: Theratears Contact Lens Comfort Drops (2003), 0 descendants of its own

## Recalls of this device
- Dec 29, 2020 · Class II · Z-0948-2021: Missing Instruction For Use insert.

## Indications for use
Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to lubricate and rewet soft and rigid gas permeable contact lenses (silicone acrylate lenses and fluorosilicone acrylate lenses). Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to help relieve dryness, discomfort and irritation that may be associated with lens wear. Use REFRESH® CONTACTS™ Lubricating and Rewetting Drops to cushion lenses by placing a drop on the lens prior to application on to the eye.

Source page: https://510kreport.com/device/K992028
Methodology: https://510kreport.com/methodology