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AMO Manufacturing USA, LLC

United States·US-MF-000023322

Last updated September 17, 2026

About

We want you to see better. Learn more about eye treatments and solutions for your eye health and vision needs at every stage of life.

Translated from the manufacturer's own website. Source

Information

Country: United States
Address: 510, Cottonwood Drive, Milpitas, United States
Website: www.jjvision.com/
LinkedIn: —
Facebook: facebook.com/JnJVision
Email: [email protected]
Phone: +1 408 273-4100
PRRC Contact: Carlos Reyes
EUDAMED SRN: US-MF-000023322
FDA FEI Number: 3006695864
DUNS Number: —

Catalogue (20)

Device	Model / Reference	Registries	Class	Status
590106an	590106AN	EUDAMED	Class IIa	Active
660065an	660065AN	EUDAMED	Class IIa	Active
0110-3443	0110-3443	EUDAMED	Class IIb	Active
0110-3442	0110-3442	EUDAMED	Class IIb	Active
J20007k	J20007K	EUDAMED	Class IIb	Active
0110-3140	0110-3140	EUDAMED	Class IIb	Active
0110-2280	0110-2280	EUDAMED	Class IIb	Active
Patient Chair	0160-6030	EUDAMEDFDA UDI	Class I	Active
CATALYS Precision Laser system	K220516	FDA 510(k)	Class II	Active
Catalys Precision Laser System	K200056	FDA 510(k)	Class II	Active
Ifs Advanced Femtosecond Laser System	K141852	FDA 510(k)	Class II	Active
CATALYS Precision Laser System	K210701	FDA 510(k)	Class II	Active
Catalys™ Precision Laser System	K223838	EUDAMEDFDA 510(k)	Class II	Active
Catalys Precision Laser System	K172002	FDA 510(k)	Class II	Active
Catalys Precision Laser System	K182083	FDA 510(k)	Class II	Active
Mobile Patient Bed	0160-6000	EUDAMEDFDA UDI	Class I	Active
Liquid Optics Interface	0180-1201	EUDAMEDFDA UDI	Class IIa	Active
Visx Star S3 Excimer Laser System (with Eye Tracker)	P990010	FDA PMA	Class III	Active
Star Excimer Laser System And Idesign Advanced Wavescan Studio	P910062	FDA PMA	Class III	Active
Star S4 Excimer Laser System With Variable Spot Scanning (vss) And Wavescan Wavefront System	P930016	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

AMO Ireland IE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 21, 2021	Z-0443-2022	—	open, classified	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 of new accounts with full user rights.
Oct 21, 2021	Z-0444-2022	—	open, classified	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 of new accounts with full user rights.
Oct 12, 2011	Z-0167-2012	—	terminated	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.
Oct 12, 2011	Z-0166-2012	—	terminated	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.
Oct 12, 2011	Z-0165-2012	—	terminated	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.
Jul 18, 2011	Z-2974-2011	—	terminated	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.
Jul 18, 2011	Z-2971-2011	—	terminated	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.
Jul 18, 2011	Z-2969-2011	—	terminated	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.
Jul 18, 2011	Z-2973-2011	—	terminated	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.
Jul 18, 2011	Z-2975-2011	—	terminated	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.
Jul 18, 2011	Z-2966-2011	—	terminated	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.
Jul 18, 2011	Z-2967-2011	—	terminated	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.
Jul 18, 2011	Z-2970-2011	—	terminated	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.
Jul 18, 2011	Z-2968-2011	—	terminated	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.
Jul 18, 2011	Z-2972-2011	—	terminated	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.
Jul 18, 2011	Z-2965-2011	—	terminated	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.
Jul 13, 2010	Z-1374-2011	—	terminated	The failure to comply with Minimum System Requirements, increased system errors could result, and a miscreated treatment table (incorrect LASIK refractive treatment) could result.