TPLC - Total Product Life Cycle

• Device: pupillometer, ac-powered
• Product Code: HLG
• Regulation Number: 886.1700
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2015	4	4
2016	6	6
2017	4	4
2018	2	2
2019	5	5
2020	1	1
2021	3	3
2022	1	1
2023	9	9
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Failure to Align	6	6
Imprecision	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Positioning Problem	3	3
Incorrect Measurement	3	3
Appropriate Term/Code Not Available	3	3
Display or Visual Feedback Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Device Operates Differently Than Expected	2	2
Inadequate User Interface	1	1
Inappropriate or Unexpected Reset	1	1
Defective Device	1	1
Malposition of Device	1	1
Insufficient Information	1	1
Optical Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Use of Device Problem	1	1
Failure to Charge	1	1
Computer Software Problem	1	1
Application Program Problem: Power Calculation Error	1	1
Incorrect Software Programming Calculations	1	1
Patient Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Known Impact Or Consequence To Patient	6	6
No Code Available	4	4
Visual Impairment	4	4
No Clinical Signs, Symptoms or Conditions	4	4
Blurred Vision	3	3
No Consequences Or Impact To Patient	2	2
Therapeutic Response, Decreased	1	1
Failure of Implant	1	1
Therapeutic Effects, Unexpected	1	1
Eye Infections	1	1
Swelling/ Edema	1	1