FDA-Device2013-07-31Class II
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Topcon Medical Laser Systems, Inc
Hazard
When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Sold states
Worldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Affected count
7 US, 33 foreign
Manufactured in
3130 Coronado Dr, N/A, Santa Clara, CA, United States
Products
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2013Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief