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U.S. Department of Health and Human Services

Class 2 Device Recall PASCAL and PASCAL Streamline

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 Class 2 Device Recall PASCAL and PASCAL Streamlinesee related information
Date Initiated by FirmMarch 27, 2012
Date PostedJuly 19, 2013
Recall Status1 Terminated 3 on July 19, 2013
Recall NumberZ-1774-2013
Recall Event ID 65688
510(K)NumberK100019 
Product Classification Laser, ophthalmic - Product Code HQF
ProductPASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Code Information PASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211                                                
FEI Number 2939653
Recalling Firm/
Manufacturer		 Topcon Medical Laser Systems, Inc
3130 Coronado Dr
Santa Clara CA 95054-3205
For Additional Information ContactJohn J. Talirico
408-792-8177
Manufacturer Reason
for Recall		When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
FDA Determined
Cause 2		Software design
ActionInitial notification was sent on March 27, 2012 to all TMLS Distribution Partners and Sales Representative. This was followed by a follow up notification on June 4, 2012. A final notice was sent on February 11, 2013 to all those who had not sent documentation that the field action had been implemented.
Quantity in Commerce7 US, 33 foreign
DistributionWorldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HQF
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