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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
2020 405 1430
2021 72 237
2022 7 689
2023 10 1001
2024 11 581
2025 5 174

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 345 345
Decrease in Suction 95 2507
Suction Problem 43 1233
Mechanical Problem 8 8
Unintended Movement 3 3
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Unsealed Device Packaging 2 2
Failure to Sense 2 2
Use of Device Problem 2 2
Device Handling Problem 2 2
Device Contaminated During Manufacture or Shipping 1 1
No Display/Image 1 1
Suction Failure 1 1
Contamination 1 1
Device Emits Odor 1 1
Insufficient Cooling 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 233 233
Blurred Vision 123 123
No Clinical Signs, Symptoms or Conditions 68 2480
Keratitis 66 66
Visual Impairment 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 31 31
Foreign Body Sensation in Eye 30 30
Pain 25 25
Corneal Clouding/Hazing 21 21
Discomfort 18 18
Dry Eye(s) 15 15
Inflammation 15 15
No Known Impact Or Consequence To Patient 15 15
Corneal Abrasion 14 14
Irritation 13 13
Halo 12 12
Corneal Infiltrates 8 8
Loss of Vision 8 8
No Consequences Or Impact To Patient 8 1198
Visual Disturbances 8 8
Erosion 7 7
Excessive Tear Production 4 4
Edema 3 3
Wrinkling 3 3
No Patient Involvement 3 3
Corneal Perforation 2 2
Tissue Breakdown 2 2
Hemorrhage/Bleeding 2 2
Corneal Edema 2 2
Eye Injury 2 2
Insufficient Information 2 2
Swelling 2 2
Burning Sensation 2 2
Rupture 2 2
Corneal Ulcer 2 2
Retinal Detachment 1 1
Conjunctivitis 1 1
Phosphene Visualization 1 1
Injury 1 1
Ulcer 1 1
Discharge 1 1
Therapeutic Response, Decreased 1 1
Hyphema 1 1
Bacterial Infection 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Headache 1 1
Macular Edema 1 1
Red Eye(s) 1 1
Uveitis 1 1
Intraocular Pressure Increased 1 1

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