Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PASCAL and PASCAL Streamline (532 nm.577 nm) Recalled by Topcon Medical Laser Systems, Inc Due to When using the "Favorites" function for saved settings,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Topcon Medical Laser Systems, Inc directly.
Affected Products
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Quantity: 7 US, 33 foreign
Why Was This Recalled?
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.
Where Was This Sold?
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.
About Topcon Medical Laser Systems, Inc
Topcon Medical Laser Systems, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report