TPLC - Total Product Life Cycle

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Device	tomography, optical coherence
Regulation Description	Ophthalmoscope.
Definition	Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Product Code	OBO
Regulation Number	886.1570
Device Class	2

Premarket Reviews
Manufacturer	Decision
C.S.O. S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, AG
	SUBSTANTIALLY EQUIVALENT	1
CARL ZEISS MEDITEC, INC.
	SUBSTANTIALLY EQUIVALENT	2
CYLITE PTY. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
HEIDELBERG ENGINEERING GMBH
	SUBSTANTIALLY EQUIVALENT	7
NIDEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OPTOS PLC.
	SUBSTANTIALLY EQUIVALENT	2
OPTOVUE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOMEY CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
TOPCON CORPORATION
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	4	4
Adverse Event Without Identified Device or Use Problem	3	3
Optical Problem	2	2
Unintended Electrical Shock	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Visual Disturbances	3	3
Retinal Injury	2	2
Capsular Bag Tear	2	2
Visual Impairment	2	2
Convulsion/Seizure	2	2
Loss of Vision	2	2
Vitreous Detachment	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Insufficient Information	1	1
Vitreous Floaters	1	1
Blurred Vision	1	1