TPLC - Total Product Life Cycle

show TPLC since

Device	system, image management, ophthalmic
Regulation Description	Medical image management and processing system.
Product Code	NFJ
Regulation Number	892.2050
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTRIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON INC.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	3
CENTERVUE SPA
	SUBSTANTIALLY EQUIVALENT	1
INTEGRATED OPHTHALMIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
KONAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT CRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
OPHTHALMIC LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
RETINAI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
TOPCON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS EMEA OY
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VISIONQUEST BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	1	1
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Incorrect Control/Treatment Settings	1	1
Data Problem	1	1
Device Handling Problem	1	1
Computer Software Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Capsular Bag Tear	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Blurred Vision	1	1