Devices

Device Recall AMO WaveScan WaveFront System v3.65

Model / Serial
All systems with software version 3.65 and earlier: Part Numbers 0070-0150, 0070-0150R, 0070-1006, 0070-1006R, and 0070-1478.
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
No
Distribution
Class 2 Recall - Worldwide Distribution: USA, Venezuela, Colombia, Italy, Saudi Arabia, Kuwait, Egypt, UAE, Jordan, Lebanon, Australia, Canada, France, Germany, India, Ireland, Japan, Sweden, Vietnam, Czech Republic, Slovak Republic, Bulgaria, Philippines, South Korea, Turkey, UK, Portugal, Spain, Argentina, Israel, Cyprus, India, Mexico, Greece, Singapore, Chile, Poland, Brazil, China, Thailand, Taiwan, Hong Kong and Russia.
Product Description
Excimer Laser System; WaveScan WaveFront System, Software Version 3.65, for use with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems. System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors and wavefront aberrations to the target shape and then generates the commands for the VISX STAR laser to create the target shape on the cones.
Manufacturer
VISX INCORPORATED, A SUBSIDIARY OF AMO INC
1 Event
- Recall of Device Recall AMO WaveScan WaveFront System v3.65

Manufacturer

VISX INCORPORATED, A SUBSIDIARY OF AMO INC

Manufacturer Address
VISX INCORPORATED, A SUBSIDIARY OF AMO INC, 3400 Central Expy, Santa Clara CA 95051-0703
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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