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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aberrometer, ophthalmic
Product CodeNCF
Regulation Number 886.1760
Device Class 1

MDR Year MDR Reports MDR Events
2019 71 71
2020 53 53
2021 46 46
2022 38 38
2023 36 36
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 98 98
Adverse Event Without Identified Device or Use Problem 52 52
Loose or Intermittent Connection 43 43
Incorrect, Inadequate or Imprecise Result or Readings 15 15
Appropriate Term/Code Not Available 12 12
Unexpected Therapeutic Results 12 12
Insufficient Information 8 8
Therapeutic or Diagnostic Output Failure 6 6
Overcorrection 5 5
Failure to Align 4 4
Unstable 3 3
Patient-Device Incompatibility 3 3
Measurement System Incompatibility 3 3
Improper or Incorrect Procedure or Method 3 3
Unintended Movement 2 2
Component Missing 2 2
Power Problem 2 2
Fitting Problem 1 1
Break 1 1
Mechanical Problem 1 1
Malposition of Device 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Application Program Problem 1 1
Device Fell 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Unable to Obtain Readings 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Calibration Problem 1 1
Detachment of Device or Device Component 1 1
Device Displays Incorrect Message 1 1
Application Program Problem: Power Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 67 67
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
No Known Impact Or Consequence To Patient 41 41
No Clinical Signs, Symptoms or Conditions 33 33
Blurred Vision 21 21
Visual Impairment 18 18
No Code Available 16 16
No Consequences Or Impact To Patient 11 11
Visual Disturbances 7 7
Therapeutic Effects, Unexpected 6 6
Failure of Implant 5 5
No Patient Involvement 5 5
Patient Problem/Medical Problem 2 2
Complaint, Ill-Defined 2 2
Halo 2 2
Nausea 1 1
Dizziness 1 1
No Information 1 1
Injury 1 1
Unspecified Eye / Vision Problem 1 1
Therapeutic Response, Decreased 1 1
Headache 1 1
Corneal Scar 1 1
Vitrectomy 1 1

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