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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 2023 2024
10 11 13 6 7 0 8 5

MDR Year MDR Reports MDR Events
2017 1359 1359
2018 1601 1601
2019 1060 1060
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2887 2887
Insufficient Information 652 652
Device Operates Differently Than Expected 213 213
Patient-Device Incompatibility 138 138
Appropriate Term/Code Not Available 136 136
Device Displays Incorrect Message 117 117
Improper or Incorrect Procedure or Method 116 116
Unexpected Therapeutic Results 110 110
Overcorrection 82 82
Energy Output Problem 71 71
Therapeutic or Diagnostic Output Failure 49 49
Gas/Air Leak 41 41
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Device Inoperable 32 32
Defective Device 28 28
Failure to Capture 25 25
Mechanical Problem 24 24
Device Emits Odor 22 22
Output Problem 21 21
Computer Software Problem 20 20
Failure to Align 19 19
Use of Device Problem 19 19
Device Sensing Problem 18 18
Electrical /Electronic Property Problem 16 16
Unintended Movement 16 16
Undercorrection 11 11
Loose or Intermittent Connection 11 11
Leak/Splash 9 9
Output above Specifications 9 9
Material Integrity Problem 9 9
Power Problem 9 9
Defective Component 8 8
Device Alarm System 8 8
Material Erosion 7 7
Noise, Audible 7 7
Calibration Problem 7 7
Optical Problem 7 7
Material Opacification 7 7
Computer System Security Problem 7 7
Output below Specifications 7 7
Misfire 7 7
Incorrect Measurement 7 7
Lack of Effect 6 6
Loss of Power 6 6
Protective Measures Problem 5 5
Failure to Power Up 5 5
Intermittent Continuity 5 5
Unintended System Motion 5 5
Self-Activation or Keying 5 5
Suction Problem 5 5
Operating System Becomes Nonfunctional 5 5
Device Stops Intermittently 5 5
Unstable 5 5
Failure to Fire 4 4
Failure to Calibrate 4 4
Poor Visibility 4 4
Inappropriate or Unexpected Reset 4 4
Patient Device Interaction Problem 4 4
Computer Operating System Problem 4 4
Fumes or Vapors 4 4
Failure to Deliver Energy 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Display or Visual Feedback Problem 4 4
Positioning Problem 4 4
Firing Problem 4 4
Mechanics Altered 3 3
Defective Alarm 3 3
Misfocusing 3 3
Device Slipped 3 3
Microbial Contamination of Device 3 3
Unexpected Shutdown 3 3
Application Program Problem 3 3
Air Leak 3 3
Use of Incorrect Control/Treatment Settings 3 3
Inadequacy of Device Shape and/or Size 3 3
Data Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 3 3
Product Quality Problem 3 3
Power Conditioning Problem 3 3
Device Reprocessing Problem 3 3
Fire 3 3
Programming Issue 3 3
Visual Prompts will not Clear 2 2
Failure to Sense 2 2
Problem with Sterilization 2 2
Measurement System Incompatibility 2 2
Communication or Transmission Problem 2 2
Device Fell 2 2
Electronic Property Issue 2 2
Intermittent Energy Output 2 2
Smoking 2 2
Capturing Problem 2 2
Pressure Problem 2 2
Detachment Of Device Component 2 2
Reset Problem 2 2
Decrease in Pressure 2 2
Material Fragmentation 2 2
Human Factors Issue 2 2
Device Handling Problem 2 2
Positioning Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Keratitis 1105 1105
Blurred Vision 1068 1068
Visual Impairment 780 781
No Code Available 582 582
No Known Impact Or Consequence To Patient 470 470
Dry Eye(s) 449 449
Pain 402 402
Increased Sensitivity 288 288
Halo 214 215
Discomfort 180 180
Visual Disturbances 177 177
Foreign Body Sensation in Eye 165 165
Inflammation 154 154
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 148 148
Corneal Clouding/Hazing 136 136
Irritation 133 133
Erosion 107 107
Corneal Abrasion 102 102
Headache 94 94
Loss of Vision 90 90
Burning Sensation 83 83
Corneal Infiltrates 83 83
No Consequences Or Impact To Patient 76 76
Vitreous Floaters 74 74
Uveitis 72 72
Red Eye(s) 70 71
Therapeutic Effects, Unexpected 67 67
Depression 66 66
Insufficient Information 62 62
No Clinical Signs, Symptoms or Conditions 59 59
Eye Pain 59 59
Hypersensitivity/Allergic reaction 56 56
Eye Injury 56 56
Impaired Healing 45 45
Excessive Tear Production 42 42
Therapeutic Response, Decreased 41 41
Itching Sensation 39 40
Swelling 37 37
Complaint, Ill-Defined 37 37
No Information 37 37
Anxiety 36 36
Glaucoma 36 36
Unspecified Infection 34 34
Corneal Ulcer 33 33
Patient Problem/Medical Problem 26 26
Reaction 24 24
Emotional Changes 24 24
Edema 24 24
Corneal Edema 23 23
Unspecified Eye / Vision Problem 23 23
Suicidal Ideation 20 20
Increased Sensitivity 18 18
Corneal Scar 18 18
Erythema 18 18
Cataract 16 16
Intraocular Pressure Increased 15 15
Nausea 13 13
Scarring 11 11
Discharge 11 11
Neuralgia 11 11
Injury 10 10
Iritis 10 10
Abrasion 10 10
Vitreous Detachment 9 9
Bacterial Infection 8 9
Conjunctivitis 8 8
Nerve Damage 8 8
Retinal Detachment 7 7
Sleep Dysfunction 7 7
Tissue Breakdown 7 7
Disability 7 7
Tissue Damage 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
Inadequate Pain Relief 6 6
Acanthameba Keratitis 6 6
Death 6 6
Fatigue 5 5
Infiltration into Tissue 5 5
Retinal Tear 5 5
Decreased Sensitivity 5 5
Vomiting 5 5
Clouding, Central Corneal 5 5
Viral Infection 4 4
Microcysts, Epithelial 4 4
No Patient Involvement 4 4
Staphylococcus Aureus 4 4
Scar Tissue 4 4
Optical Nerve Damage 4 4
Neuropathy 4 4
Laceration(s) 3 3
Cataract, Induced 3 3
Eye Burn 3 3
Weight Changes 3 3
Coma 3 3
Distress 3 3
Vertigo 3 3

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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