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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 7 312

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 88 2066
Mechanical Problem 20 20
Appropriate Term/Code Not Available 6 6
Energy Output Problem 4 4
Failure to Cut 3 3
Scratched Material 3 3
Unintended Movement 3 3
Insufficient Information 2 2
Device Handling Problem 2 2
Patient-Device Incompatibility 2 2
Unsealed Device Packaging 2 2
Failure to Sense 2 2
Use of Device Problem 2 2
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Computer Software Problem 1 1
Contamination 1 1
Insufficient Cooling 1 1
Calibration Problem 1 1
Expulsion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Device Emits Odor 1 1
Optical Problem 1 1
Positioning Problem 1 1
Suction Failure 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
Discomfort 62 62
No Clinical Signs, Symptoms or Conditions 60 2038
Irritation 54 54
Corneal Clouding/Hazing 53 53
Corneal Abrasion 39 39
Dry Eye(s) 37 37
Halo 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
Loss of Vision 8 8
Edema 8 8
Contusion 6 6
Corneal Ulcer 5 5
Swelling 5 5
Burning Sensation 5 5
Discharge 4 4
Uveitis 4 4
Macular Edema 4 4
Eye Injury 3 3
Conjunctivitis 3 3
Corneal Edema 3 3
Corneal Perforation 3 3
Unspecified Infection 3 3
No Patient Involvement 3 3
Tissue Breakdown 2 2
Irritability 2 2
Insufficient Information 2 2
Rupture 2 2
Corneal Scar 2 2
Headache 2 2
Hemorrhage/Bleeding 2 2
Hyphema 1 1
Vitreous Floaters 1 1
Corneal Decompensation 1 1
Bacterial Infection 1 1
Cellulitis 1 1
Retinal Detachment 1 1
Itching Sensation 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1
Intraocular Pressure Increased 1 1
Iritis 1 1
Phosphene Visualization 1 1
Vomiting 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Clouding, Central Corneal 1 1
Injury 1 1
Increased Sensitivity 1 1

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