510(k) Report

510(k) · Cleared

Recalled · 2008

The Amo Ophthalmic Surgical System

K060366510(k) AbbreviatedCleared Apr 7, 200653-day reviewClass II21 CFR 886.4670Recalls 1

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. · HQC Unit, Phacofragmentation

Cleared on Apr 7, 2006 as substantially equivalent to K003638 (Allergan, Inc., 2001) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1991. 32 later devices descend from it. It has been recalled once.

Decided
Apr 7, 2006
Review
53 days
Class
Class II
Product code
HQC
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K911808 (1991). 3 ancestors in all. 32 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor1996: 1 other ancestor2016: 1 descendant cleared2011: 2 descendants cleared2009: 2 descendants cleared2006: 1 descendant cleared2012: 1 descendant cleared2014: 5 descendants cleared2010: 1 descendant cleared2015: 3 descendants cleared2017: 3 descendants cleared2021: 1 descendant cleared2024: 4 descendants cleared2020: 1 descendant cleared2019: 2 descendants cleared2022: 2 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2025: 1 descendant clearedK911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 10 descendants3 generations forward: 12 descendants4 generations forward: 4 descendants K911808 · Gemini Ophthalmic Surgery System · Alcon Laboratories · 1991 · recalled0
  1. Root · 1 generation backK911808 Gemini Ophthalmic Surgery SystemAlcon Laboratories · 1991 · Recalled
  2. This deviceK060366 The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc. · 2006
  3. Descendant · cites it directly · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
  5. Descendant · 2 generations on · 14 of its ownK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
  6. Descendant · cites it directly · 8 of its ownK081877 Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009
  7. Descendant · 3 generations on · 7 of its ownK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · Recalled

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2006: 12009: 22010: 12011: 22012: 12014: 52015: 32016: 12017: 32019: 22020: 12021: 12022: 22023: 12024: 42025: 12026: 1
2006high 5 (2014) · low 0 (2007)2026

Most influential descendants

Showing 5 of 32 · See all
  • K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · cites it directly24descendants
  • K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 2 generations on22descendants
  • K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · 2 generations on14descendants
  • K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV · 2009 · cites it directly8descendants
  • K133486Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911808Gemini Ophthalmic Surgery SystemAlcon Laboratories19912
0 (this device)K060366The Amo Ophthalmic Surgical SystemAdvanced Medical Optics, Inc.2006—
+1K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc.200612
+2K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc.20094
+2K101325Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc.20101
+1K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV2009—
+3K133486Stellaris PC Vision Enhancement SystemBausch & Lomb20143

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200920
201010
201120
201210
201450
201530
201610
201730
201920
202010
202110
202220
202310
202440
202510
202610
FIG. 1 — Lineage of K060366, 1991–2026Source: 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 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 HQC? 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 HQC device

  1. #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 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

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.

TypeNumberDeviceApplicantDecidedRecalls
*K003638Mojave Cataract Extraction System
Summary page 1
…agmentation System The devices to which substantial equivalence is claimed: 510(k) Numbe CerneDate Device K003638 0213/2001 Mojave Cataract Extraction System…
Allergan, Inc.2001—
*K911808Gemini Ophthalmic Surgery System
Summary page 1
…(Marketed as the Sovereign Compact Cataract ____ ____ ___ __ ___ ____ ___ ___ Extraction System ) K91 1808 06/25/1991 Gemini Ophthalmic Surgery System…
Alcon Laboratories19912
*K961310Storz Premiere II Microsurgical System (CX Series)
Summary page 1
…(Marketed as the Series 20000 Legacy and Accurus _____________Ophthalmic Systems) K961310 06/27/96 Premiere II Microsurgical System…
Storz Instrument Co.19961

Also cleared against K003638: 1 other device →

What descends from it? (32)

See all 32

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc.200624
K081877Associate 2500 Dual and Compact SystemsDutch Ophthalmic Research Center International BV20098
K121555Centurion Vision SystemAlcon Laboratories, Inc.20126
K111446Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc.20114
K111697Amo Whitestar Signature Phacoemulsification SystemAbbott Medical Optics, Inc.20112
K160236Dual Pump PackAbbott Medical Optics, Inc.20161

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

Recalls of this device

DateClassRecallRoot causeReason
Apr 2, 2008Not classifiedZ-1702-2008Device DesignAMO initiated this field correction event after becoming aware of a trend in complaints associated with AMO Vitrectomy Cutter used in conjunction with the AMO WHITESTAR SIGNATURE Phacoemulsification System. The physician may be unable to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K063331 (Bausch & Lomb, Inc., 2006) has gone furthest, with 24 descendants of its own.
  • 1 other device also cites its predicate K003638.

How does its category compare?

All HQC devices

HQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQC

3in 2025

2008: 42009: 52010: 32011: 52012: 52014: 42015: 32016: 12017: 32019: 42020: 42021: 12022: 42023: 12024: 52025: 32026 (partial year): 3
2007high 5 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQC

267in 2025

2008: 162 days median2009: 131 days median2010: 142 days median2011: 129 days median2012: 125 days median2014: 135 days median2015: 124 days median2017: 214 days median2019: 126 days median2020: 227 days median2022: 245 days median2024: 197 days median2025: 267 days median2026 (partial year): 115 days median
2007high 267 (2025) · low 124 (2015)2026

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

Recalls per year · HQC

1in 2025

2008: 12009: 12010: 222011: 42012: 12014: 12018: 22022: 52023: 12025: 1
2007high 22 (2010) · low 0 (2007)2026

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

Adverse event reports per year · HQC

1,799in 2025

2007: 3412008: 4442009: 5402010: 2,4312011: 1,8022012: 2,2772013: 2,7722014: 2,7402015: 3,3552016: 3,3742017: 2,7812018: 2,4162019: 2,2872020: 1,2172021: 1,6732022: 1,9072023: 1,7992024: 2,1202025: 1,799
2007high 3,374 (2016) · low 341 (2007)2025

MAUDE reports naming product code HQC, 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
20070—0341
200841621444
200951311540
20103142222,431
2011512941,802
2012512512,277
20130—02,772
2014413512,740
2015312403,355
20161—03,374
2017321402,781
20180—22,416
2019412602,287
2020422701,217
20211—01,673
2022424551,907
20231—11,799
2024519702,120
2025326711,799
202631150—

What is it indicated for?

The AMO Ophthalmic Surgical System is a modular ophthalmic microsurgical system that facilitates both anterior segment (i.e., cataract) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The posterior segment surgery module is optional. The modular design allows the users to configure the system to meet their surgical requirements.

Indications for use as stated in the FDA summary.

Also cleared against K003638

1 other device cites the same predicate.

  • K111446Sovereign Compact Phacoemulsification SystemAbbott Medical Optics, Inc. · 20111 recall

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
  • K042562Lens Plus Rewetting DropsAdvanced Medical Optics, Inc. · 2005
  • K050648Sovereign High Vacuum Pack, Sovereign Compact High Vacuum PackAdvanced Medical Optics, Inc. · 2005

Recent decisions in HQC

The HQC category page

  • K262097MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)Carl Zeiss Meditec Cataract Technologies · 2026
  • K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s): 23 ga. Posterior…Bausch and Lomb · 2026
  • K252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated · 2026
  • K250501System SophiThis AG · 2025
  • K243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc. · 2025

https://510kreport.com/device/K060366 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060366: The Amo Ophthalmic Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060366

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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