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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
Product CodeHNO
Regulation Number 886.4370
Device Class 1

MDR Year MDR Reports MDR Events
2019 816 2642
2020 405 1430
2021 72 237
2022 7 689
2023 10 1001
2024 11 581

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1028 1028
Suction Problem 147 3163
Decrease in Suction 92 2335
Mechanical Problem 20 20
Appropriate Term/Code Not Available 6 6
Energy Output Problem 4 4
Unintended Movement 3 3
Scratched Material 3 3
Failure to Cut 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
Expulsion 1 1
Device Contaminated During Manufacture or Shipping 1 1
No Display/Image 1 1
Suction Failure 1 1
Positioning Problem 1 1
Contamination 1 1
Calibration Problem 1 1
Optical Problem 1 1
Device Emits Odor 1 1
Computer Software Problem 1 1
Insufficient Cooling 1 1
Electrical /Electronic Property Problem 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 693 693
Blurred Vision 370 370
Keratitis 291 291
Visual Impairment 157 157
Foreign Body Sensation in Eye 78 78
Pain 77 77
No Clinical Signs, Symptoms or Conditions 64 2307
Discomfort 62 62
Irritation 54 54
Corneal Clouding/Hazing 53 53
Corneal Abrasion 39 39
Halo 37 37
Dry Eye(s) 37 37
Inflammation 36 36
No Known Impact Or Consequence To Patient 33 33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Corneal Infiltrates 30 30
Visual Disturbances 28 28
Erosion 26 26
No Consequences Or Impact To Patient 21 3037
Excessive Tear Production 10 10
Wrinkling 10 10
Red Eye(s) 9 9
Edema 8 8
Loss of Vision 8 8
Contusion 6 6
Corneal Ulcer 5 5
Burning Sensation 5 5
Swelling 5 5
Uveitis 4 4
Macular Edema 4 4
Discharge 4 4
Corneal Perforation 3 3
Corneal Edema 3 3
Eye Injury 3 3
No Patient Involvement 3 3
Conjunctivitis 3 3
Unspecified Infection 3 3
Insufficient Information 2 2
Headache 2 2
Hemorrhage/Bleeding 2 2
Rupture 2 2
Irritability 2 2
Corneal Scar 2 2
Tissue Breakdown 2 2
Vomiting 1 1
Retinal Detachment 1 1
Phosphene Visualization 1 1
Injury 1 1
Cellulitis 1 1

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