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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device keratome, ac-powered
Regulation Description Keratome.
Product CodeHNO
Regulation Number 886.4370
Device Class 1

MDR Year MDR Reports MDR Events
2021 72 237
2022 7 689
2023 10 1001
2024 11 581
2025 10 314
2026 3 116

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 96 2756
Adverse Event Without Identified Device or Use Problem 8 8
Failure to Sense 2 2
Use of Device Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
Patient-Device Incompatibility 1 1
Insufficient Information 1 1
Contamination 1 1
Device Handling Problem 1 1
Suction Problem 1 166

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 71 2731
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Visual Impairment 4 4
Dry Eye(s) 3 3
Visual Disturbances 3 3
Corneal Clouding/Hazing 2 2
Keratitis 2 2
Eye Injury 2 2
Corneal Perforation 2 2
Halo 1 1
Corneal Abrasion 1 1
Unspecified Eye / Vision Problem 1 1
Insufficient Information 1 1
Pain 1 1
Blurred Vision 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 166
Eye Pain 1 1
Distress 1 1
Increased Sensitivity 1 1

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