Recall Z-1774-2013— Topcon Medical Laser Systems, Inc

Name: FDA recall Z-1774-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-27

Class II · Terminated

Class II FDA medical device recall by Topcon Medical Laser Systems, Inc, initiated 2012-03-27, terminated 2013-07-19. It names one FDA 510(k) clearance: K100019. Product: PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.. 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: Topcon Medical Laser Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2012-03-27
Terminated: 2013-07-19
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K100019 — PASCAL STREAMLINE PHOTOCOAGULATOROptimedica Corporation·cleared 2010-05-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.