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	24	24
Adverse Event Without Identified Device or Use Problem	14	14
Insufficient Information	13	13
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
Application Program Version or Upgrade Problem	1	1
Operating System Version or Upgrade Problem	1	1
High Readings	1	1
Battery Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Difficult to Program or Calibrate	1	1
Data Problem	1	1
Power Problem	1	1
Self-Activation or Keying	1	1
Misassembly During Maintenance/Repair	1	1
Product Quality Problem	1	1
No Apparent Adverse Event	1	1
Application Program Problem: Parameter Calculation Error	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Visual Impairment	59	59
No Clinical Signs, Symptoms or Conditions	9	9
No Known Impact Or Consequence To Patient	9	9
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Unspecified Eye / Vision Problem	2	2