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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
2021 46 46
2022 38 38
2023 36 36
2024 34 34
2025 39 39
2026 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect Measurement 83 83
Incorrect, Inadequate or Imprecise Result or Readings 58 58
Adverse Event Without Identified Device or Use Problem 34 34
Loose or Intermittent Connection 18 18
Insufficient Device Problem Information 7 7
Appropriate Device Problem Term/Code Not Available 2 2
Failure to Align 2 2
Defective Component 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 77 77
Insufficient Information 74 74
No Clinical Signs, Symptoms or Conditions 29 29
Blurred Vision 28 28
Visual Impairment 26 26
Visual Disturbances 9 9
Halo 2 2
Eye Pain 2 2
Dry Eye(s) 1 1
Corneal Edema 1 1
Photophobia 1 1
Unspecified Eye / Vision Problem 1 1
No Information 1 1
Nausea 1 1
Dizziness 1 1
Eye Irritation 1 1
Therapeutic Response, Decreased 1 1
Failure of Implant 1 1
Corneal Scar 1 1
Headache 1 1

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