Jul

2013

Cl ll PASCAL and PASCAL Streamline

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

___________________________________

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl ll PASCAL and PASCAL Streamline

Amy Sellers

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