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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pupillometer, ac-powered
Product CodeHLG
Regulation Number 886.1700
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 3 3
2022 1 1
2023 9 9
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 6 6
Failure to Align 6 6
Appropriate Term/Code Not Available 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Positioning Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Failure to Charge 1 1
Use of Device Problem 1 1
Inappropriate or Unexpected Reset 1 1
Display or Visual Feedback Problem 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Blurred Vision 3 3
Failure of Implant 1 1
No Code Available 1 1
Capsular Bag Tear 1 1
No Known Impact Or Consequence To Patient 1 1
Eye Infections 1 1
Swelling/ Edema 1 1

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