International Medical Devices Database

Manufacturer Address
Topcon Medical Laser Systems, Inc, 3130 Coronado Dr, Santa Clara CA 95054-3205
Manufacturer Parent Company (2017)
Topcon Corporation
Source
USFDA
2 Events
- Recall of Device Recall PASCAL and PASCAL Streamline
- Recall of Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar

2 devices in the database

Device Recall PASCAL and PASCAL Streamline

Model / Serial
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
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
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.
Product Description
PASCAL and PASCAL Streamline (532 nm.577 nm); || Treats the patient's eye.

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.

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Topcon Medical Laser Systems, Inc

2 devices in the database

Device Recall PASCAL and PASCAL Streamline

Device Recall PASCAL Synthesis and Pascal Synthesis TwinStar