Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The Recalled by Topcon Medical Laser Systems, Inc Due to Topcon discovered an anomaly with titration, only when...
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
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
Quantity: 205 units (21 in US, 184 OUS)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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