FDA-Device2016-08-17Class II
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Topcon Medical Laser Systems, Inc
Hazard
Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode.
Sold states
Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.
Affected count
205 units (21 in US, 184 OUS)
Manufactured in
3130 Coronado Dr, Santa Clara, CA, United States
Products
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2016Don't want to check this manually?
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