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Topcon Medical Laser Systems Recalls
2 recalls on record · July 31, 2013 to August 17, 2016 · Medical Devices
Recalls by year
13
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 17, 2016Medical DevicesFDA
Topcon Medical Laser Systems, Inc recalls Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation
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.
July 31, 2013Medical DevicesFDA
Topcon Medical Laser Systems, Inc recalls PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
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.