TPLC - Total Product Life Cycle

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Device	biomicroscope, slit-lamp, ac-powered
Product Code	HJO
Regulation Number	886.1850
Device Class	2

Premarket Reviews
Manufacturer	Decision
CYLITE PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
KOWA COMPANY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIMAGING INTEGRATED SOLUTION INC. (MIIS)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	21	21
Insufficient Information	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Incorrect, Inadequate or Imprecise Result or Readings	9	9
Incorrect Measurement	9	9
Patient Data Problem	6	6
Output Problem	4	4
Device Fell	2	2
Calibration Problem	2	2
Misassembly During Maintenance/Repair	1	1
Power Problem	1	1
No Apparent Adverse Event	1	1
Data Problem	1	1
Self-Activation or Keying	1	1
Operating System Version or Upgrade Problem	1	1
Application Program Problem: Parameter Calculation Error	1	1
Device Difficult to Program or Calibrate	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1
High Readings	1	1
Application Program Version or Upgrade Problem	1	1
Battery Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Visual Impairment	55	55
No Known Impact Or Consequence To Patient	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Insufficient Information	5	5
Unspecified Eye / Vision Problem	2	2