TPLC - Total Product Life Cycle

• 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
1.  K122938  FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM A ...
2.  K123464  CALLISTO EYE
3.  K130648  FORUM GLAUCOMA WORKPLACE
4.  K141297  FORUM GLAUCOMA WORKPLACE
5.  K150467  Retina Workplace
6.  K170638  Retina Workplace
7.  K180858  CALLISTO eye
8.  K213527  FORUM
9.  K231676  CALLISTO eye
10.  K232944  CALLISTO eye
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

MDR Year	MDR Reports	MDR Events
2014	1	1
2015	2	2
2016	29	29
2017	4	4
2019	2	2
2021	1	1
2022	2	2

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Bausch & Lomb Inc	II	May-26-2010
2	Carl Zeiss Meditec AG	II	Feb-04-2015
3	Diagnos Inc	II	Mar-25-2022
4	Haag-Streit USA Inc	II	Mar-20-2017
5	Kowa Optimed Inc	II	Dec-17-2020
6	Merge Healthcare, Inc.	II	Jul-10-2017
7	Merge Healthcare, Inc.	II	Apr-15-2017
8	Merge Healthcare, Inc.	II	Mar-13-2017
9	Merge Healthcare, Inc.	II	Feb-23-2017
10	Topcon Medical Systems, Inc.	II	Feb-04-2021
11	Topcon Medical Systems, Inc.	II	Apr-12-2019