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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 Streamline see related information
Date Initiated by Firm March 27, 2012
Date Posted July 19, 2013
Recall Status1 Terminated 3 on July 19, 2013
Recall Number Z-1774-2013
Recall Event ID 65688
510(K)Number K100019  
Product Classification Laser, ophthalmic - Product Code HQF
Product PASCAL 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                                                
Recalling Firm/
Manufacturer		 Topcon Medical Laser Systems, Inc
3130 Coronado Dr
Santa Clara CA 95054-3205
For Additional Information Contact John 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
Action Initial 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 Commerce 7 US, 33 foreign
Distribution Worldwide 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 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 = OPTIMEDICA CORPORATION
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