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TPLC
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Device
keratome, ac-powered
Regulation Description
Keratome.
Product Code
HNO
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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