Data / Medical devices / United States / AMO Manufacturing USA, LLC
AMO Manufacturing USA, LLC: FDA-registered device maker in Milpitas, CA, United States, 21 510(k) clearances and 1 PMA approval
AMO Manufacturing USA, LLC is registered with the FDA (registration 3006695864) in Milpitas, CA, United States. It lists 5 device types. The FDA files 21 510(k) clearances and 1 PMA approval under its listings, the newest dated April 14, 2023. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006695864
- Address
- 510 Cottonwood Drive, Milpitas, CA, United States, 95035
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- ELITA Femtosecond Laser System, ELITA Patient Interface 1-pack, ELITA Patient Interface 20-pack, Excimer laser system, Gen3 LOI, Keratome, ac-powered, Ophthalmic Femtosecond Laser, Ophthalmic femtosecond laser and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Excimer Laser System | LZS | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Keratome, Ac-Powered | HNO | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ophthalmic Femtosecond Laser | OOE | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Unit, Phacofragmentation | HQC | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2023 | K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | OOE | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| May 17, 2022 | K220516 | CATALYS Precision Laser system | OOE | Substantially Equivalent | Amo Manufacturing USA, LLC | accessdata.fda.gov |
| April 7, 2021 | K210701 | CATALYS Precision Laser System | OOE | Substantially Equivalent | Amo Manufacturing USA, LLC | accessdata.fda.gov |
| March 12, 2021 | K203060 | VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control | HQC | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| May 18, 2020 | K200056 | Catalys Precision Laser System | OOE | Substantially Equivalent | Amo Manufacturng USA, LLC | accessdata.fda.gov |
| November 9, 2018 | K182083 | Catalys Precision Laser System | OOE | Substantially Equivalent | Amo Manufacturing USA, LLC | accessdata.fda.gov |
| August 25, 2017 | K172002 | Catalys Precision Laser System | OOE | Substantially Equivalent | Amo Manufacturing USA, LLC | accessdata.fda.gov |
| May 19, 2017 | K170322 | Catalys Precision Laser System | OOE | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| September 20, 2016 | K161455 | Catalys Precision Laser System | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| October 19, 2015 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| January 6, 2015 | K141852 | IFS ADVANCED FEMTOSECOND LASER SYSTEM | GEX | Substantially Equivalent | Amo Manufacturing USA, LLC | accessdata.fda.gov |
| September 11, 2014 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| February 27, 2014 | K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| August 28, 2012 | K121091 | CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| March 8, 2012 | K113151 | IFS LASER SYSTEM | GEX | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| December 21, 2011 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | Substantially Equivalent | Optimedica Corporation | accessdata.fda.gov |
| December 21, 2011 | K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM | HQC | Substantially Equivalent | Abbott Medical Optics, Inc. | accessdata.fda.gov |
| April 25, 2008 | K073404 | IFS LASER SYSTEM | GEX | Substantially Equivalent | Intra Lase Corp. | accessdata.fda.gov |
| August 16, 2006 | K060372 | INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3 | GEX | Substantially Equivalent | Intra Lase Corp. | accessdata.fda.gov |
| April 7, 2006 | K060366 | THE AMO OPHTHALMIC SURGICAL SYSTEM | HQC | Substantially Equivalent | Advanced Medical Optics, Inc. | accessdata.fda.gov |
| July 29, 2005 | K041893 | INTRALASE FS LASER | GEX | Substantially Equivalent | Intra Lase Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 27, 1996 | P930016 | VISX EXCIMER LASER SYSTEM MODELS B AND C | LZS | 62 | August 9, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 21, 2021 | 88986 | Class II | Ongoing | iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studio Aberrometer (International) and (United States), Model: G301 | Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged file operations. This could be exploited to run arbitrary code with SYSTEM privileges, allowing for program installation; view/change/deleting data; or creation | accessdata.fda.gov |
| May 9, 2018 | 80849 | Class II | Terminated | OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 | Software upgrade exhibits failures when executing Daily Alignment Verification (DAV), specifically, cuts on the plastic hemisphere during DAV do not match the intended cuts shown on the treatment overlay screen on the system GUI. | accessdata.fda.gov |
| February 20, 2015 | 70679 | Class II | Terminated | OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens. | Device may experience loss of suction during treatment resulting in scoring the cornea during lens fragmentation. | accessdata.fda.gov |
| September 16, 2013 | 66304 | Class II | Terminated | STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in | This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB). | accessdata.fda.gov |
| May 28, 2013 | 65285 | Class II | Terminated | STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomile | Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. | accessdata.fda.gov |
| May 23, 2013 | 65292 | Class II | Terminated | Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. | Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery. | accessdata.fda.gov |
| October 12, 2011 | 60241 | Not yet classified | Terminated | Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended | The firm has identified a discrepancy in cut depth that may affect deep corneal incisions (e.g. 300 m or deeper) created using the Laser System. | accessdata.fda.gov |
| July 18, 2011 | 59330 | Not yet classified | Terminated | STAR S4 IR Excimer Laser System; Software Version 5.00 Mfg by : AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 Iris registration is designed to compensate for pupil centroid shift and cycloration, bot | Reports of lower success rates with Iris Registration (IR) image capture with the STAR S4 IR Excimer Laser System v 5.3 that with previous version. | accessdata.fda.gov |
| July 13, 2010 | 56394 | Not yet classified | Terminated | AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.: Version 3.67, US version; 0070-1668; I | The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Phacofragmentation
- All makers of Powered Laser Surgical Instrument
- All makers of Keratome, Ac-Powered
- All makers of Ophthalmic Femtosecond Laser
- All makers of Excimer Laser System
Updated August 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.