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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


Premarket Reviews
ManufacturerDecision
CARL ZEISS MEDITEC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2265 2265
2019 816 2642
2020 405 1430
2021 72 237
2022 7 689

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1886 1886
Suction Problem 1498 4514
Decrease in Suction 76 758
Mechanical Problem 23 23
Device Operates Differently Than Expected 18 18
Device Displays Incorrect Message 6 6
Appropriate Term/Code Not Available 6 6
Insufficient Information 5 5
Scratched Material 4 4
Failure to Cut 4 4
Unintended Movement 4 4
Energy Output Problem 4 4
Use of Device Problem 3 3
Patient-Device Incompatibility 3 3
Optical Problem 2 2
Positioning Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Electrical /Electronic Property Problem 2 2
Smoking 2 2
Unsealed Device Packaging 2 2
Failure to Sense 2 2
Accessory Incompatible 2 2
Computer Software Problem 2 2
Contamination 2 2
Temperature Problem 2 2
Device Handling Problem 2 2
Suction Failure 1 1
Insufficient Cooling 1 1
Break 1 1
Device Emits Odor 1 1
No Display/Image 1 1
Device Slipped 1 1
Sticking 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
Electrical Shorting 1 1
Expulsion 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Defective Component 1 1
Failure to Advance 1 1
Dent in Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1300 4316
No Code Available 1213 1213
Blurred Vision 624 624
Keratitis 587 587
Visual Impairment 290 290
Pain 143 143
Foreign Body Sensation in Eye 143 143
Discomfort 102 102
Irritation 90 90
Dry Eye(s) 88 88
Visual Disturbances 78 78
Corneal Clouding/Hazing 75 75
Halo 74 74
Inflammation 66 66
Corneal Abrasion 59 59
Erosion 52 52
Corneal Infiltrates 48 48
No Known Impact Or Consequence To Patient 47 47
No Clinical Signs, Symptoms or Conditions 47 729
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Excessive Tear Production 29 29
Burning Sensation 26 26
Wrinkling 24 24
Red Eye(s) 19 19
Loss of Vision 13 13
Unspecified Infection 11 11
Edema 10 10
Corneal Edema 9 9
Uveitis 9 9
Corneal Ulcer 8 8
Itching Sensation 7 7
Headache 7 7
Contusion 6 6
Iritis 6 6
Swelling 6 6
No Patient Involvement 6 6
Discharge 5 5
Conjunctivitis 5 5
Bacterial Infection 4 4
Hemorrhage/Bleeding 4 4
Macular Edema 4 4
Eye Injury 4 4
Vitreous Floaters 4 4
Intraocular Pressure Increased 3 3
Corneal Scar 3 3
Retinal Detachment 3 3
Corneal Perforation 2 2
Rupture 2 2
Tissue Breakdown 2 2
Insufficient Information 2 2
Irritability 2 2
Vitreous Detachment 2 2
Burn, Thermal 2 2
Cognitive Changes 1 1
Therapeutic Response, Decreased 1 1
Ulcer 1 1
Anxiety 1 1
Increased Sensitivity 1 1
Injury 1 1
Fungal Infection 1 1
Overwear Syndrome 1 1
Clouding, Central Corneal 1 1
Ulceration 1 1
Phosphene Visualization 1 1
Dizziness 1 1
Vomiting 1 1
Corneal Decompensation 1 1
Bruise/Contusion 1 1
Cellulitis 1 1
Herpes 1 1
Hyphema 1 1
Increased Sensitivity 1 1
Nausea 1 1
Intraocular Pressure, Delayed, Uncontrolled 1 1

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