BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2405-2016 · Initiated July 15, 2016

    Recall

    Recall Number
    Z-2405-2016
    Event Number
    74724
    Firm
    Topcon Medical Laser Systems, Inc
    FEI Number
    2939653
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 15, 2016
    Terminated
    January 29, 2019
    Address
    3130 Coronado Dr, Santa Clara, CA, 95054-3205

    Description

    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.

    Action

    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].

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Canada, Mexico, Japan, Netherlands, Algeria, Australia, Brazil, Chile, China, France, Guatemala, Hong Kong, Italy, New Zealand, Pakistan, Philippines, Singapore, Taiwan, and United Kingdom.

    Quantity

    205 units (21 in US, 184 OUS)