510(k) Report

PMA · Approved

Approved

Complete Brand Lubricating and Rewetting Drops

P910075/S007PMAApproved Sep 13, 1996134-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Medical Optics, Inc. · LPN Accessories, Soft Lens Products

Approved on Sep 13, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 134-day review. 4 later devices descend from it.

Decided
Sep 13, 1996
Review
134 days
Class
Class II
Product code
LPN
Recalls
None

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2019: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared1995200020052010201520202025
  1. This deviceP910075/S007 Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc. · 1996
  2. Descendant · cites it directly · 3 of its ownK992028 Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK083812 Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009
  4. Descendant · 2 generations on · 0 of its ownK190674 REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019
  5. Descendant · 2 generations on · 0 of its ownK032481 Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K992028Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc. · 1999 · cites it directly3descendants
  • K083812Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc. · 2009 · 2 generations on1descendant
  • K190674REFRESH RELIEVA For CONTACTSAllergan, Inc. · 2019 · 2 generations on0descendants
  • K032481Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P910075/S007Complete Brand Lubricating and Rewetting DropsAdvanced Medical Optics, Inc.1996—
+1K992028Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc.19991
+2K083812Refresh Optive Lens Comfort Rewetting DropsAllergan, Inc.2009—
+2K190674REFRESH RELIEVA For CONTACTSAllergan, Inc.2019—
+2K032481Theratears Contact Lens Comfort DropsAdvanced Vision Research, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
200910
201910
FIG. 1 — Lineage of P910075/S007, 1996–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), 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. #1 K253795 MeniSept 3% Hydrogen Peroxide Cleaning &…score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992028Refresh Contacts Lubricating and Rewetting DropsAllergan, Inc.19993

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K992028 (Allergan, Inc., 1999) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LPN devices

LPN Accessories, Soft Lens Products: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LPN

2in 2022

2007: 42009: 12010: 22011: 32012: 22013: 22015: 22016: 32017: 12019: 22020: 32021: 22022: 22026 (partial year): 1
2007high 4 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPN

167in 2020

2007: 175 days median2011: 222 days median2016: 59 days median2020: 167 days median
2007high 222 (2011) · low 59 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPN

1in 2020

2007: 22009: 22010: 22011: 12016: 12020: 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPN

40in 2025

2007: 1,1512008: 1532009: 1212010: 2412011: 2732012: 2682013: 842014: 1052015: 1762016: 4982017: 2,6662018: 952019: 602020: 822021: 512022: 622023: 842024: 762025: 40
2007high 2,666 (2017) · low 40 (2025)2025

MAUDE reports naming product code LPN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007417521,151
20080—0153
20091—2121
20102—2241
201132221273
20122—0268
20132—084
20140—0105
20152—0176
20163591498
20171—02,666
20180—095
20192—060
20203167182
20212—051
20222—062
20230—084
20240—076
20250—040
20261—0—

More from Advanced Medical Optics, Inc.

669 FDA decisions under this applicant name. See the company

  • K081681Vitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. · 20082 recalls
  • K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc. · 2008
  • P810055/S072Ceeon Ultraviolet Light-Absorbing Polymethylmethacrylate (Pmma) Posterior Chamber Intraocular Lenses (Iols)Advanced Medical Optics, Inc. · 2008
  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20061 recall
  • K042562Lens Plus Rewetting DropsAdvanced Medical Optics, Inc. · 2005

Recent decisions in LPN

The LPN category page

  • K253795MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting SolutionMenicon Co, Ltd. · 2026
  • K222541Bausch + Lomb Preservative Free Lubricating and Rewetting DropsBausch & Lomb, Incorporated · 2022
  • K221263Aqua Naina Plus Sterile Saline SolutionChemtex USA, Inc. · 2022
  • K202932ABT12 multi-purpose solutionBausch & Lomb, Incorporated · 2021
  • K210051OTE MPS 045 Multi-purpose Lens Care SolutionOte North America, LLC · 2021

https://510kreport.com/device/P910075/S007 · printed Nov 6, 2026

Cite this page

510(k) Report. “P910075/S007: Complete Brand Lubricating and Rewetting Drops.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910075/S007

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026