Company:Topcon Medical Laser Systems, Inc
Date of Enforcement Report: 7/31/2013
Class ll:
PRODUCT
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient’s eye.
Recall Number Z-1774-2013
REASON
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.
RECALLING FIRM/MANUFACTURER
Topcon Medical Laser Systems, Inc., Santa Clara, CA on 3/27/2012. Voluntary: Firm Initiated recall has been terminated.
VOLUME OF PRODUCT IN COMMERCE
7 US, 33 foreign
DISTRIBUTION
Nationwide and Internationally
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