Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 4 229

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1027 1027
Suction Problem 147 3163
Decrease in Suction 86 1984
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
Unsealed Device Packaging 2 2
Device Handling Problem 2 2
Insufficient Information 2 2
Use of Device Problem 2 2
Failure to Sense 2 2
Patient-Device Incompatibility 2 2
Suction Failure 1 1
Contamination 1 1
No Display/Image 1 1
Insufficient Cooling 1 1
Electrical /Electronic Property Problem 1 1
Calibration Problem 1 1
Positioning Problem 1 1
Computer Software Problem 1 1
Expulsion 1 1
Device Emits Odor 1 1
Mechanical Jam 1 1
Optical Problem 1 1
Device Contaminated During Manufacture or Shipping 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 58 1956
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
Unspecified Infection 3 3
No Patient Involvement 3 3
Tissue Breakdown 2 2
Irritability 2 2
Insufficient Information 2 2
Rupture 2 2
Corneal Perforation 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

-
-