TPLC - Total Product Life Cycle

• Device: biomicroscope, slit-lamp, ac-powered
• Regulation Description: AC-powered slitlamp biomicroscope.
• 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

MDR Year	MDR Reports	MDR Events
2020	19	19
2021	14	14
2022	6	6
2023	18	18
2024	18	18
2025	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	23	23
Adverse Event Without Identified Device or Use Problem	14	14
Insufficient Information	9	9
Incorrect, Inadequate or Imprecise Result or Readings	9	9
Incorrect Measurement	8	8
Patient Data Problem	6	6
Output Problem	3	3
High Readings	3	3
Device Fell	2	2
Calibration Problem	2	2
Application Program Version or Upgrade Problem	1	1
Operating System Version or Upgrade Problem	1	1
Battery Problem	1	1
Misassembly During Maintenance/Repair	1	1
Device Difficult to Program or Calibrate	1	1
Application Program Problem: Parameter Calculation Error	1	1
Product Quality Problem	1	1
Power Problem	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Visual Impairment	54	54
No Clinical Signs, Symptoms or Conditions	10	10
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Unspecified Eye / Vision Problem	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Carl Zeiss Meditec AG	II	Feb-18-2021
2	Haag-Streit USA Inc	II	May-11-2021