510(k) Report

FDA applicant

Advanced Medical Optics, Inc.

Santa Ana18 decisions1980–20083 recalls

FDA records 18 decisions for Advanced Medical Optics, Inc. (Santa Ana) from 1980 to 2008: 8 510(k) clearances and 10 original PMA approvals. Most are in product codes HQL (Intraocular Lens) and LPN (Accessories, Soft Lens Products). Its devices cite 8 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

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

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Advanced Medical Optics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2018

2008: 12017: 12018: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Advanced Medical Optics, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Advanced Medical Optics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HQLIntraocular Lens8decisions
  • LPNAccessories, Soft Lens Products3decisions
  • HQCUnit, Phacofragmentation2decisions
  • LPMLenses, Soft Contact, Extended Wear2decisions
  • MRCProducts, Contact Lens Care, Rigid Gas Permeable1decision
  • MLZVitrectomy, Instrument Cutter1decision

Also: MSS (1).

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 12 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20066cite it
  • K030092Complete Brand Multi-Purpose SolutionAdvanced Medical Optics, Inc. · 20032cite it
  • K042562Lens Plus Rewetting DropsAdvanced Medical Optics, Inc. · 20051cites it
  • K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc. · 20081cites it
  • K032030Blink CL Lubricant Eye DropsAdvanced Medical Optics, Inc. · 20031cites it
  • P830047X-70 Soft Contact LensAdvanced Medical Optics, Inc. · 19851cites it

What has FDA decided for it lately?

  • K081681Vitrectomy Cutter and AccessoriesAdvanced Medical Optics, Inc. · 20082 recalls
  • K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc. · 2008
  • K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 20061 recall
  • K042562Lens Plus Rewetting DropsAdvanced Medical Optics, Inc. · 2005
  • K050648Sovereign High Vacuum Pack, Sovereign Compact High Vacuum PackAdvanced Medical Optics, Inc. · 2005
  • K040839Complete Blink-N-Clean Lens DropsAdvanced Medical Optics, Inc. · 2004
  • K032030Blink CL Lubricant Eye DropsAdvanced Medical Optics, Inc. · 2003
  • K030092Complete Brand Multi-Purpose SolutionAdvanced Medical Optics, Inc. · 2003

All 18 as Advanced Medical Optics, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K081681Disposable 25GA Vitrectomy Cutter, REF NGP0025, RX Only, Abbott Medical Optics Inc., The…Sep 24, 2018Class II
  • K081681AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and…Mar 30, 2017Class II
  • K060366Opthalmic microsurgical system-AMO WHITESTAR SIGNATURE Phacoemulsification System…Apr 2, 2008