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

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.

The firm, PASCALS Synthesis, sent an "Urgent Field Safety notification" letter dated July 15, 2016 to all affected sites by traceable method. The letter described the product, problem and actions to be taken. The customers were instructed to Acknowledge the receipt of the field notice via an official letter; locate all systems with Endpoint Management software feature enabled; for all affected units- inform the physician, hospital or institution customers of the addendum and additional warnings issued as a result of this notice; obtain signed confirmation from the end-user regarding receipt of the addendum and additional warnings; send the signed confirmation from ALL end-users to TMLS, no later than October 15, 2016; and complete to the following record "Products lines affected" for all affected units and either fax to (408) 235-8259 or scan and email to [email protected]. Contact Customer Care if you have questions at: 1.408.235.8200 or email: [email protected].