STAR S4 IR

ophthalmological technology

Medical Device Safety Alert: [20 Jul 2011] Abbott Medical Optics (AMO) STAR S4 IR Excimer Laser System Software, Versions 5.00 through 5.22 and Versions 5.00 through 5.30

Ophthalmology Equipment

Model # 0030-4817

Ophthalmic Devices

3

No

Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.

STAR S4 IR Excimer Laser System; Software Version 5.18 || Mfg by : AMO Manufacturing USA, LLC || 510 Cottonwood Drive || Milpitas, CA 95035 || Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.

Model # 0030-4639

Ophthalmic Devices

3

No

Worldwide Distribution-USA (nationwide) including Puerto Rico and countries of Africa, Asian Pacific, Canada, Europe, Japan, Latin America, and the Middle East.

STAR S4 IR Excimer Laser System; Software Version 5.02 || Mfg by : AMO Manufacturing USA, LLC || 510 Cottonwood Drive || Milpitas, CA 95035 || Iris registration is designed to compensate for pupil centroid shift and cycloration, both of Which may occur because of patient characteristics and the different environments at the time of measurement and at the time of treatment.