510(k) · Cleared
Recalled · Class II · 2020Refresh Contacts Lubricating and Rewetting Drops
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allergan, Inc. · LPN Accessories, Soft Lens Products
Cleared on Oct 7, 1999 as substantially equivalent to P910075/
- Decided
- Oct 7, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- LPN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to P910075/
- Root · 1 generation backP910075/
S007 Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc. · 1996 - This deviceK992028 Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK083812 Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK190674 REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK032481 Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K083812Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009 · cites it directly1descendant
- K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019 · cites it directly0descendants
- K032481Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P910075/ | Complete Brand Lubricating and Rewetting Drops | Advanced Medical Optics, Inc. | 1996 | — |
| 0 (this device) | K992028 | Refresh Contacts Lubricating and Rewetting Drops | Allergan, Inc. | 1999 | — |
| +1 | K083812 | Refresh Optive Lens Comfort Rewetting Drops | Allergan, Inc. | 2009 | — |
| +1 | K190674 | REFRESH RELIEVA For CONTACTS | Allergan, Inc. | 2019 | — |
| +1 | K032481 | Theratears Contact Lens Comfort Drops | Advanced Vision Research, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPN device
- #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P960012 | Refresh CL (TM)/Lubricating and Reweting Drops FDA lists this PMA only through its supplements; the earliest we hold is P960012/S001 (Apr 24, 1997). Summary page 3…in terms of action, indications for use, safety and effectiveness to the predicate devices, REFRESH® CL Lubricating and Rewetting Drops (approved for marketing under PMA P960012), COMPLETE® Lubricating and Rewetting Drops (approved for marketing under P910075/S7) and CLARIS® Rewetting Drops (approved for m… | |
| * | P910075/ | Complete Brand Lubricating and Rewetting Drops A supplement to the PMA, as the summary prints it. | 1996 |
| * | P900047 | Wet-N-Soak (TM) Rewetting Drops FDA lists this PMA only through its supplements; the earliest we hold is P900047/S002 (Apr 5, 1994). Summary page 3…rketing under PMA P960012), COMPLETE® Lubricating and Rewetting Drops (approved for marketing under P910075/S7) and CLARIS® Rewetting Drops (approved for marketing under P900047/SS). Any differences between the new device and its predicates do not effect the use of this product. September 1999 Page 13 of… |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 29, 2020 | Class II | Z-0948-2021 | Employee error | Missing Instruction For Use insert. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K083812 (Allergan, Inc., 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LPN devicesLPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPN
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LPN
167in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPN
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPN
40in 2025
MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 175 | 2 | 1,151 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 1 | — | 2 | 121 |
| 2010 | 2 | — | 2 | 241 |
| 2011 | 3 | 222 | 1 | 273 |
| 2012 | 2 | — | 0 | 268 |
| 2013 | 2 | — | 0 | 84 |
| 2014 | 0 | — | 0 | 105 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 3 | 59 | 1 | 498 |
| 2017 | 1 | — | 0 | 2,666 |
| 2018 | 0 | — | 0 | 95 |
| 2019 | 2 | — | 0 | 60 |
| 2020 | 3 | 167 | 1 | 82 |
| 2021 | 2 | — | 0 | 51 |
| 2022 | 2 | — | 0 | 62 |
| 2023 | 0 | — | 0 | 84 |
| 2024 | 0 | — | 0 | 76 |
| 2025 | 0 | — | 0 | 40 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992028: Refresh Contacts Lubricating and Rewetting Drops.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992028
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026