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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
GEBAUER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
MORIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 453 453
2015 966 966
2016 1397 1397
2017 2112 2112
2018 2265 2265
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
Suction Problem 4383 7399
Adverse Event Without Identified Device or Use Problem 3667 3667
Device Operates Differently Than Expected 157 157
Decrease in Suction 98 1996
Device Displays Incorrect Message 43 43
Scratched Material 34 34
Failure to Cut 34 34
Mechanical Problem 29 29
Insufficient Information 18 18
Unexpected Therapeutic Results 13 13
Appropriate Term/Code Not Available 12 12
Failure to Advance 9 9
Device Contamination with Chemical or Other Material 7 7
Unintended Movement 5 5
Smoking 5 5
Energy Output Problem 5 5
Noise, Audible 4 4
Patient-Device Incompatibility 3 3
Electrical /Electronic Property Problem 3 3
Use of Device Problem 3 3
Failure to Power Up 3 3
Therapy Delivered to Incorrect Body Area 2 2
Retraction Problem 2 2
Failure to Sense 2 2
Malposition of Device 2 2
Accessory Incompatible 2 2
Break 2 2
Thermal Decomposition of Device 2 2
Computer Software Problem 2 2
Contamination 2 2
Unsealed Device Packaging 2 2
Poor Quality Image 2 2
Device Emits Odor 2 2
Device Expiration Issue 2 2
Temperature Problem 2 2
Optical Problem 2 2
Positioning Problem 2 2
Device Handling Problem 2 2
Suction Failure 1 1
Power Problem 1 1
Electrical Shorting 1 1
Expulsion 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Detachment of Device or Device Component 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Jam 1 1
No Flow 1 1
Gradient Increase 1 1
Migration or Expulsion of Device 1 1
Misassembled 1 1
Use of Incorrect Control/Treatment Settings 1 1
Insufficient Cooling 1 1
Energy Output To Patient Tissue Incorrect 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Folded 1 1
Failure to Fire 1 1
Dent in Material 1 1
Expiration Date Error 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Device Slipped 1 1
Reflux within Device 1 1
Improper or Incorrect Procedure or Method 1 1
Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4036 7052
No Code Available 2423 2423
Keratitis 1116 1116
Blurred Vision 1097 1097
Visual Impairment 590 590
Dry Eye(s) 248 248
Foreign Body Sensation in Eye 242 242
No Known Impact Or Consequence To Patient 241 241
Pain 240 240
Inflammation 178 178
Irritation 169 169
Discomfort 138 138
Corneal Clouding/Hazing 134 134
Halo 119 119
Visual Disturbances 118 118
Corneal Abrasion 118 118
Wrinkling 91 91
Unspecified Infection 89 89
Erosion 74 74
Corneal Infiltrates 63 63
No Clinical Signs, Symptoms or Conditions 58 1956
Red Eye(s) 55 55
Excessive Tear Production 48 48
Burning Sensation 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Uveitis 25 25
Corneal Edema 24 24
Edema 23 23
Loss of Vision 20 20
Itching Sensation 18 18
Corneal Ulcer 18 18
Headache 16 16
Swelling 12 12
Iritis 12 12
Foreign Body In Patient 12 12
No Patient Involvement 11 11
Corneal Perforation 10 10
Conjunctivitis 9 9
Eye Injury 8 8
Discharge 8 8
Intraocular Pressure Increased 7 7
Contusion 6 6
Hemorrhage/Bleeding 5 5
Vitreous Floaters 4 4
Bacterial Infection 4 4
Corneal Scar 4 4
Macular Edema 4 4
Retinal Detachment 4 4
Tissue Breakdown 4 4
Cataract 3 3
Intraocular Infection 3 3
Foreign Body Reaction 2 2
Extrusion 2 2
Bruise/Contusion 2 2
Nausea 2 2
Tissue Damage 2 2
Rupture 2 2
Ulcer 2 2
Capsular Bag Tear 2 2
Vitrectomy 2 2
Irritability 2 2
Vitreous Detachment 2 2
Burn, Thermal 2 2
Insufficient Information 2 2
Increased Sensitivity 1 1
Cognitive Changes 1 1
Reaction, Injection Site 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Depression 1 1
Impaired Healing 1 1
Reaction 1 1
Fungal Infection 1 1
Patient Problem/Medical Problem 1 1
Lead(s), Burn(s) From 1 1
Fibrosis 1 1
Anxiety 1 1
Viral Infection 1 1
Therapeutic Response, Decreased 1 1
Microcysts, Epithelial 1 1
Overwear Syndrome 1 1
Clouding, Central Corneal 1 1
Phosphene Visualization 1 1
Dizziness 1 1
Vomiting 1 1
Optical Tissue, Breakdown Of 1 1
Ulceration 1 1
Ventricular Flutter 1 1
Vertigo 1 1
Neovascularization 1 1
Positive antinuclear antibodies (ANA) 1 1
Staphylococcus Aureus 1 1
Increased Sensitivity 1 1
Abrasion 1 1
Cellulitis 1 1
Corneal Stromal Edema 1 1
Corneal Decompensation 1 1
Herpes 1 1
Hypersensitivity/Allergic reaction 1 1
Hyphema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Nov-04-2011
2 Med-logics Inc II Mar-13-2015
3 Wavelight AG II May-25-2011
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