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U.S. Department of Health and Human Services

Class 2 Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar

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  Class 2 Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar see related information
Date Initiated by Firm July 15, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 on January 29, 2019
Recall Number Z-2405-2016
Recall Event ID 74724
510(K)Number K123542  
Product Classification Laser, ophthalmic - Product Code HQF
Product

Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed
conventionally.
Code Information 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. 
Recalling Firm/
Manufacturer
Topcon Medical Laser Systems, Inc
3130 Coronado Dr
Santa Clara CA 95054-3205
For Additional Information Contact Sweta Srivastava
408-235-8206
Manufacturer 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.
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 205 units (21 in US, 184 OUS)
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HQF and Original Applicant = TOPCON MEDICAL LASER SYSTEMS, INC
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