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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

Device Problems MDRs with this Device Problem Events in those MDRs
Decrease in Suction 93 2640
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 68 2615
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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