TPLC - Total Product Life Cycle

show TPLC since

Device	system, image management, ophthalmic
Product Code	NFJ
Regulation Number	892.2050
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTRIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON INC.
	SUBSTANTIALLY EQUIVALENT	1
CANON INC. -MEDICAL EQUIPMENT GROUP
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC AG
	SUBSTANTIALLY EQUIVALENT	10
CARL ZEISS MEDITEC, INC
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, INC.
	SUBSTANTIALLY EQUIVALENT	1
DIAGNOS, INC
	SUBSTANTIALLY EQUIVALENT	1
EYEIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EYEKOR, LLC.
	SUBSTANTIALLY EQUIVALENT	1
HAAG-STREIT AG
	SUBSTANTIALLY EQUIVALENT	1
HUVITZ CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
INTEGRATED OPHTHALMIC SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTELLIGENT RETINAL IMAGING SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
KONAN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
KOWA CO. LTD. CHOFU
	SUBSTANTIALLY EQUIVALENT	1
MERIT CRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEUROVISION IMAGING, LLC
	SUBSTANTIALLY EQUIVALENT	1
NIDEK CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OPHTHALMIC IMAGING SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
OPHTHALMIC LABS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OPTOS PLC
	SUBSTANTIALLY EQUIVALENT	2
RETINAI MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
SONOMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOPCON CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TOPCON HEALTHCARE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS EMEA OY
	SUBSTANTIALLY EQUIVALENT	1
TOPCON HEALTHCARE SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOPCON MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	5
VISIONQUEST BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELCH ALLYN, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Data Problem	11	11
Patient Data Problem	7	7
Device Operates Differently Than Expected	7	7
Poor Quality Image	7	7
Loss of Data	5	5
Computer Software Problem	5	5
Device Operational Issue	3	3
Programming Issue	2	2
Device Issue	2	2
Application Program Problem	2	2
Computer Operating System Problem	1	1
Connection Problem	1	1
Use of Incorrect Control/Treatment Settings	1	1
Disconnection	1	1
Image Resolution Poor	1	1
Improper or Incorrect Procedure or Method	1	1
Improper Device Output	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Problem with Software Installation	1	1
Device Handling Problem	1	1
Program or Algorithm Execution Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	35	35
No Code Available	1	1
Unspecified Eye / Vision Problem	1	1
Insufficient Information	1	1
Corneal Touch	1	1
Retinal Tear	1	1
Blurred Vision	1	1
No Consequences Or Impact To Patient	1	1
Capsular Bag Tear	1	1
No Patient Involvement	1	1