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U.S. Department of Health and Human Services

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

MDR Year MDR Reports MDR Events
2020 53 53
2021 46 46
2022 38 38
2023 36 36
2024 34 34
2025 39 39
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 95 95
Incorrect, Inadequate or Imprecise Result or Readings 60 60
Adverse Event Without Identified Device or Use Problem 44 44
Loose or Intermittent Connection 25 25
Insufficient Information 8 8
Appropriate Term/Code Not Available 7 7
Therapeutic or Diagnostic Output Failure 5 5
Unexpected Therapeutic Results 5 5
Failure to Align 3 3
Unstable 2 2
Overcorrection 2 2
Patient-Device Incompatibility 2 2
Measurement System Incompatibility 2 2
Improper or Incorrect Procedure or Method 2 2
Break 1 1
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Application Program Problem 1 1
Unintended Movement 1 1
Defective Component 1 1
Unable to Obtain Readings 1 1
Positioning Failure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Calibration Problem 1 1
Power Problem 1 1
Application Program Problem: Power Calculation Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 85 85
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
No Clinical Signs, Symptoms or Conditions 36 36
Blurred Vision 32 32
Visual Impairment 28 28
No Known Impact Or Consequence To Patient 18 18
Visual Disturbances 9 9
Halo 2 2
Failure of Implant 2 2
No Code Available 2 2
Eye Pain 2 2
Complaint, Ill-Defined 1 1
Nausea 1 1
Dizziness 1 1
No Information 1 1
Dry Eye(s) 1 1
Injury 1 1
Unspecified Eye / Vision Problem 1 1
Corneal Edema 1 1
Therapeutic Response, Decreased 1 1
Headache 1 1
Therapeutic Effects, Unexpected 1 1
No Consequences Or Impact To Patient 1 1
Corneal Scar 1 1
Vitrectomy 1 1

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