Events

Recall of Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Topcon Medical Laser Systems, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74724
  • Event Risk Class
    Class 2
  • Event Number
    Z-2405-2016
  • Event Initiated Date
    2016-07-15
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148296
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laser, ophthalmic - Product Code HQF
  • 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 tmlsinfo@topcon.com. Contact Customer Care if you have questions at: 1.408.235.8200 or email: tmlsinfo@topcon.com.

Device

Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar
  • Model / Serial
    Model PASCAL Synthesis (532/577). Serial numbers: United States: 79056215 79064615 77055414 79065715 79088615 79088415 79063115 79081015 79095816 79085715 77050213 77050313 77052113 77052913 79088916 79081615 77051913 77052313 77053113 79071415 79073815 77053613 79081515. ROW: 79087915 79073715 79074915 79075415 79075515 79076315   79076515   79076715 79076915   77055714   79050314 79050614   79050714 79050914 79051114 79051214 79051414 79051714 79052114 79052214 79052314 79052714 79052814 79052914 79053014 79053214 79053314 79054014 79054114 79054214 79054414 79054714 79054814 79055014 79055314 79055414 79055715 79057915 79058015 79058115 79058215 79059715 79059815 79064315 79065115 79065215 79065415 79065915 79067515 79067615 79067715 79068015 79068115 79068715 79069915 79070515 79071115 79072415 79072615 79072715 79072815 79072915 79073215 79073315 79073615 79077415 79077915 79078015 79079515 79082115 79084815 79086815 79086915 79087615 79088315 79089116 79090316 79090516 79090616 79093816 79094416 79095416 79095516 79074015 79074315 79074515 77052613 78051014 78051414 78051514 79051914 79053514 79053614 79053814 79053914 79054914 79056615 79057015 79057115 79057315 79057615 79058515 79060015 79060115 79060215 79060315 79060415 79060515 79060915 79061015 79061115 79061215 79061315 79061415 79061715 79062115 79062515 79062615 79062715 79062815    79063315    79063815    79063915 79064115 79064515 79064815 79065015 79065515 79066315 79066415 79066515 79066915 79068315 79068415 79068815 79070315 79070715 79070815 79070915 79071315 79071815 79072015   79080815 79080915   79081115 79082715 79082915 79083015 79084215 79085015 79087015 79087115 79093416 77055113 77055213 79068615 79069815 79091916 77055914 77053913 77054013 77054113 77054213 77054313 79077315 79091116 77055514 79058615 79059415 79071515 79063415 79066615 79063015 78050414 79061615 79062915 79066115 79070115 79092016 79092316 79092416 79079915.
  • Product Classification
    Ophthalmic Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed || conventionally.
  • Manufacturer
    Topcon Medical Laser Systems, Inc

Manufacturer

Topcon Medical Laser Systems, Inc
  • Manufacturer Address
    Topcon Medical Laser Systems, Inc, 3130 Coronado Dr, Santa Clara CA 95054-3205
  • Manufacturer Parent Company (2017)
    Topcon Corporation
  • Source
    USFDA