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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 3 87

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 344 344
Decrease in Suction 94 2421
Suction Problem 43 1233
Mechanical Problem 8 8
Unintended Movement 3 3
Use of Device Problem 2 2
Unsealed Device Packaging 2 2
Insufficient Information 2 2
Failure to Sense 2 2
Device Handling Problem 2 2
Patient-Device Incompatibility 2 2
Insufficient Cooling 1 1
Suction Failure 1 1
No Display/Image 1 1
Device Emits Odor 1 1
Contamination 1 1
Device Contaminated During Manufacture or Shipping 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 67 2394
Keratitis 66 66
Visual Impairment 48 48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Foreign Body Sensation in Eye 30 30
Pain 25 25
Corneal Clouding/Hazing 21 21
Discomfort 18 18
Dry Eye(s) 15 15
No Known Impact Or Consequence To Patient 15 15
Inflammation 15 15
Corneal Abrasion 14 14
Irritation 13 13
Halo 12 12
Loss of Vision 8 8
No Consequences Or Impact To Patient 8 1198
Corneal Infiltrates 8 8
Visual Disturbances 8 8
Erosion 7 7
Excessive Tear Production 4 4
Edema 3 3
No Patient Involvement 3 3
Wrinkling 3 3
Swelling 2 2
Insufficient Information 2 2
Hemorrhage/Bleeding 2 2
Burning Sensation 2 2
Corneal Edema 2 2
Corneal Perforation 2 2
Tissue Breakdown 2 2
Rupture 2 2
Eye Injury 2 2
Corneal Ulcer 2 2
Intraocular Pressure Increased 1 1
Macular Edema 1 1
Increased Sensitivity 1 1
Injury 1 1
Bacterial Infection 1 1
Ulcer 1 1
Discharge 1 1
Clouding, Central Corneal 1 1
Uveitis 1 1
Retinal Detachment 1 1
Conjunctivitis 1 1
Unspecified Infection 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Hyphema 1 1
Therapeutic Response, Decreased 1 1

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