Recall Z-2405-2016— Topcon Medical Laser Systems, Inc

Name: FDA recall Z-2405-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-15

Class II · Terminated

Class II FDA medical device recall by Topcon Medical Laser Systems, Inc, initiated 2016-07-15, terminated 2019-01-29. It names one FDA 510(k) clearance: K123542. Product: Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.. Reason: 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..

Recalling firm: Topcon Medical Laser Systems, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-15
Terminated: 2019-01-29
Firm location: Santa Clara, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123542 — PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASERTopcon Medical Laser Systems, Inc.·cleared 2013-05-15

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

Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.

Reason for recall

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.

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