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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)
2018 2019 2020 2021 2022 2023
11 13 6 7 0 2

MDR Year MDR Reports MDR Events
2018 1601 1601
2019 1060 1060
2020 563 563
2021 263 263
2022 153 153
2023 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2285 2285
Insufficient Information 278 278
Patient-Device Incompatibility 110 110
Appropriate Term/Code Not Available 96 96
Improper or Incorrect Procedure or Method 89 89
Device Operates Differently Than Expected 76 76
Unexpected Therapeutic Results 74 74
Overcorrection 69 69
Device Displays Incorrect Message 67 67
Energy Output Problem 59 59
Therapeutic or Diagnostic Output Failure 49 49
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Gas/Air Leak 29 29
Defective Device 27 27
Mechanical Problem 24 24
Output Problem 20 20
Computer Software Problem 19 19
Failure to Capture 18 18
Failure to Align 17 17
Device Sensing Problem 16 16
Device Emits Odor 15 15
Use of Device Problem 12 12
Electrical /Electronic Property Problem 11 11
Undercorrection 11 11
Material Integrity Problem 9 9
Optical Problem 7 7
Power Problem 7 7
Computer System Security Problem 7 7
Unintended Movement 7 7
Leak/Splash 7 7
Loose or Intermittent Connection 7 7
Incorrect Measurement 7 7
Device Inoperable 7 7
Material Opacification 7 7
Misfire 6 6
Material Erosion 6 6
Output above Specifications 6 6
Noise, Audible 6 6
Lack of Effect 6 6
Calibration Problem 6 6
Protective Measures Problem 5 5
Device Alarm System 5 5
Defective Component 5 5
Loss of Power 5 5
Self-Activation or Keying 5 5
Unintended System Motion 4 4
Display or Visual Feedback Problem 4 4
Failure to Calibrate 4 4
Failure to Deliver Energy 4 4
Intermittent Continuity 4 4
Inappropriate or Unexpected Reset 4 4
Patient Device Interaction Problem 4 4
Firing Problem 4 4
Unexpected Shutdown 3 3
Operating System Becomes Nonfunctional 3 3
Inadequate Instructions for Non-Healthcare Professional 3 3
Mechanics Altered 3 3
Positioning Problem 3 3
Application Program Problem 3 3
Failure to Fire 3 3
Computer Operating System Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Air Leak 3 3
Misfocusing 3 3
Suction Problem 3 3
Microbial Contamination of Device 3 3
Unstable 3 3
Failure to Power Up 3 3
Product Quality Problem 3 3
Inadequacy of Device Shape and/or Size 3 3
Device Slipped 2 2
Failure to Sense 2 2
Decrease in Pressure 2 2
Power Conditioning Problem 2 2
Problem with Sterilization 2 2
Device Stops Intermittently 2 2
No Device Output 2 2
Fire 2 2
Component Falling 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Defective Alarm 2 2
Device Reprocessing Problem 2 2
Malposition of Device 2 2
Capturing Problem 2 2
Communication or Transmission Problem 2 2
Output below Specifications 2 2
Pressure Problem 2 2
Intermittent Energy Output 2 2
Device Fell 2 2
Torn Material 2 2
Device Handling Problem 2 2
Activation Failure 1 1
Data Problem 1 1
Intermittent Loss of Power 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Failure to Clean Adequately 1 1
Programming Issue 1 1
Reset Problem 1 1
Optical Discoloration 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Keratitis 813 813
Blurred Vision 751 751
Visual Impairment 566 567
No Code Available 409 409
No Known Impact Or Consequence To Patient 322 322
Dry Eye(s) 299 299
Pain 297 297
Increased Sensitivity 172 172
Halo 162 163
Visual Disturbances 150 150
Foreign Body Sensation in Eye 137 137
Discomfort 135 135
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 119 119
Inflammation 103 103
Corneal Clouding/Hazing 95 95
Irritation 89 89
Corneal Abrasion 79 79
Erosion 76 76
Uveitis 66 66
Corneal Infiltrates 65 65
Headache 64 64
Loss of Vision 62 62
Burning Sensation 61 61
No Clinical Signs, Symptoms or Conditions 54 54
Insufficient Information 54 54
Red Eye(s) 53 54
Vitreous Floaters 50 50
Therapeutic Effects, Unexpected 50 50
No Consequences Or Impact To Patient 48 48
Depression 48 48
Eye Pain 45 45
Therapeutic Response, Decreased 40 40
Impaired Healing 37 37
Eye Injury 35 35
Glaucoma 35 35
Hypersensitivity/Allergic reaction 34 34
Swelling 28 28
Excessive Tear Production 27 27
Itching Sensation 27 28
Patient Problem/Medical Problem 26 26
Complaint, Ill-Defined 24 24
Corneal Ulcer 23 23
Anxiety 22 22
No Information 21 21
Unspecified Infection 18 18
Emotional Changes 18 18
Unspecified Eye / Vision Problem 18 18
Corneal Edema 18 18
Reaction 16 16
Edema 16 16
Intraocular Pressure Increased 14 14
Corneal Scar 14 14
Erythema 13 13
Cataract 12 12
Increased Sensitivity 12 12
Neuralgia 11 11
Abrasion 9 9
Suicidal Ideation 9 9
Nausea 8 8
Tissue Damage 7 7
Tissue Breakdown 7 7
Iritis 7 7
Scarring 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Retinal Detachment 6 6
Conjunctivitis 6 6
Disability 6 6
Vitreous Detachment 6 6
Sleep Dysfunction 6 6
Death 6 6
Clouding, Central Corneal 5 5
Nerve Damage 5 5
Injury 5 5
Decreased Sensitivity 5 5
Neuropathy 4 4
Vomiting 4 4
Bacterial Infection 4 5
Ulcer 4 4
Discharge 4 4
Microcysts, Epithelial 3 3
Foreign Body In Patient 3 3
Fatigue 3 3
Scar Tissue 3 3
Laceration(s) 3 3
No Patient Involvement 3 3
Inadequate Pain Relief 3 3
Weight Changes 3 3
Optical Nerve Damage 3 3
Retinal Tear 3 3
Viral Infection 3 3
Dizziness 3 3
Distress 3 3
Staphylococcus Aureus 3 3
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 2 2
Memory Loss/Impairment 2 2
Cognitive Changes 2 2
Abdominal Distention 2 2
Eye Infections 2 2
Purulent Discharge 2 2

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Dec-29-2021
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