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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device excimer laser system
Product CodeLZS
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
10 11 13 6 7 0

MDR Year MDR Reports MDR Events
2017 1359 1359
2018 1601 1601
2019 1060 1060
2020 563 563
2021 263 263
2022 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2794 2794
Insufficient Information 652 652
Device Operates Differently Than Expected 213 213
Appropriate Term/Code Not Available 132 132
Patient-Device Incompatibility 125 125
Device Displays Incorrect Message 117 117
Improper or Incorrect Procedure or Method 116 116
Unexpected Therapeutic Results 108 108
Overcorrection 82 82
Energy Output Problem 67 67
Therapeutic or Diagnostic Output Failure 49 49
Gas/Air Leak 38 38
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Device Inoperable 32 32
Defective Device 28 28
Mechanical Problem 24 24
Device Emits Odor 22 22
Computer Software Problem 20 20
Failure to Align 20 20
Output Problem 19 19
Device Sensing Problem 18 18
Unintended Movement 16 16
Electrical /Electronic Property Problem 16 16
Failure to Capture 15 15
Use of Device Problem 13 13
Undercorrection 11 11
Loose or Intermittent Connection 11 11
Leak/Splash 9 9
Output above Specifications 9 9
Power Problem 9 9
Material Integrity Problem 9 9
Device Alarm System 8 8
Incorrect Measurement 7 7
Material Erosion 7 7
Material Opacification 7 7
Defective Component 7 7
Calibration Problem 7 7
Computer System Security Problem 7 7
Optical Problem 7 7
Output below Specifications 7 7
Noise, Audible 7 7
Misfire 6 6
Loss of Power 6 6
Failure to Power Up 5 5
Self-Activation or Keying 5 5
Suction Problem 5 5
Unstable 5 5
Device Stops Intermittently 5 5
Protective Measures Problem 5 5
Operating System Becomes Nonfunctional 4 4
Positioning Problem 4 4
Patient Device Interaction Problem 4 4
Firing Problem 4 4
Fumes or Vapors 4 4
Failure to Fire 4 4
Computer Operating System Problem 4 4
Inappropriate or Unexpected Reset 4 4
Failure to Calibrate 4 4
Unintended System Motion 4 4
Failure to Deliver Energy 4 4
Intermittent Continuity 4 4
Display or Visual Feedback Problem 4 4
Device Reprocessing Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Defective Alarm 3 3
Air Leak 3 3
Misfocusing 3 3
Product Quality Problem 3 3
Microbial Contamination of Device 3 3
Power Conditioning Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 3 3
Mechanics Altered 3 3
Application Program Problem 3 3
Unexpected Shutdown 3 3
Programming Issue 3 3
Data Problem 3 3
Device Handling Problem 2 2
Reset Problem 2 2
Pressure Problem 2 2
Intermittent Energy Output 2 2
Device Fell 2 2
Torn Material 2 2
Malposition of Device 2 2
Capturing Problem 2 2
Communication or Transmission Problem 2 2
Inadequate Instructions for Non-Healthcare Professional 2 2
Measurement System Incompatibility 2 2
Human Factors Issue 2 2
Electronic Property Issue 2 2
Smoking 2 2
Problem with Sterilization 2 2
Incorrect Or Inadequate Test Results 2 2
Visual Prompts will not Clear 2 2
Failure to Sense 2 2
Decrease in Pressure 2 2
No Device Output 2 2
Fire 2 2
Fluid/Blood Leak 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Keratitis 1086 1086
Blurred Vision 1046 1046
Visual Impairment 719 720
No Code Available 582 582
No Known Impact Or Consequence To Patient 470 470
Dry Eye(s) 411 411
Pain 397 397
Increased Sensitivity 288 288
Halo 198 199
Discomfort 180 180
Visual Disturbances 164 164
Foreign Body Sensation in Eye 164 164
Inflammation 153 153
Corneal Clouding/Hazing 134 134
Irritation 133 133
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 112 112
Erosion 107 107
Corneal Abrasion 99 99
Headache 91 91
Burning Sensation 83 83
Corneal Infiltrates 83 83
Loss of Vision 78 78
No Consequences Or Impact To Patient 76 76
Uveitis 71 71
Red Eye(s) 68 69
Therapeutic Effects, Unexpected 67 67
Vitreous Floaters 61 61
Eye Injury 56 56
Hypersensitivity/Allergic reaction 55 55
Depression 54 54
No Clinical Signs, Symptoms or Conditions 53 53
Insufficient Information 46 46
Impaired Healing 44 44
Excessive Tear Production 42 42
Therapeutic Response, Decreased 41 41
Itching Sensation 38 39
Swelling 37 37
Complaint, Ill-Defined 37 37
No Information 37 37
Glaucoma 35 35
Unspecified Infection 34 34
Corneal Ulcer 33 33
Eye Pain 31 31
Anxiety 29 29
Patient Problem/Medical Problem 26 26
Reaction 24 24
Edema 24 24
Corneal Edema 22 22
Emotional Changes 21 21
Erythema 18 18
Corneal Scar 17 17
Unspecified Eye / Vision Problem 16 16
Intraocular Pressure Increased 15 15
Nausea 12 12
Increased Sensitivity 12 12
Scarring 11 11
Cataract 11 11
Discharge 11 11
Injury 10 10
Neuralgia 10 10
Abrasion 10 10
Iritis 9 9
Vitreous Detachment 9 9
Bacterial Infection 8 9
Conjunctivitis 8 8
Nerve Damage 7 7
Tissue Damage 7 7
Sleep Dysfunction 7 7
Suicidal Ideation 7 7
Tissue Breakdown 7 7
Disability 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Dizziness 6 6
Ulcer 6 6
Foreign Body In Patient 6 6
Retinal Detachment 6 6
Death 6 6
Fatigue 5 5
Infiltration into Tissue 5 5
Acanthameba Keratitis 5 5
Decreased Sensitivity 5 5
Clouding, Central Corneal 5 5
Vomiting 5 5
Microcysts, Epithelial 4 4
Viral Infection 4 4
Inadequate Pain Relief 4 4
No Patient Involvement 4 4
Retinal Tear 4 4
Staphylococcus Aureus 4 4
Scar Tissue 4 4
Optical Nerve Damage 4 4
Laceration(s) 3 3
Neuropathy 3 3
Cataract, Induced 3 3
Weight Changes 3 3
Coma 3 3
Distress 3 3
Vertigo 3 3
Phototoxicity 2 2

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Dec-29-2021
2 Nidek Inc II Mar-20-2017
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