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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)
2019 2020 2021 2022 2023 2024
13 6 7 0 8 5

MDR Year MDR Reports MDR Events
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 1478 1478
Patient-Device Incompatibility 76 76
Energy Output Problem 51 51
Therapeutic or Diagnostic Output Failure 48 48
Appropriate Term/Code Not Available 41 41
Insufficient Information 39 39
Improper or Incorrect Procedure or Method 36 36
Overcorrection 34 34
Unexpected Therapeutic Results 26 26
Failure to Capture 25 25
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Device Displays Incorrect Message 22 22
Mechanical Problem 19 19
Defective Device 18 18
Gas/Air Leak 18 18
Output Problem 15 15
Undercorrection 11 11
Use of Device Problem 11 11
Failure to Align 11 11
Computer Software Problem 10 10
Device Sensing Problem 8 8
Computer System Security Problem 7 7
Misfire 7 7
Device Emits Odor 7 7
Material Opacification 7 7
Electrical /Electronic Property Problem 6 6
Material Integrity Problem 6 6
Lack of Effect 6 6
Unintended Movement 5 5
Defective Component 5 5
Leak/Splash 5 5
Device Alarm System 5 5
Unintended System Motion 5 5
Loss of Power 4 4
Incorrect Measurement 4 4
Intermittent Continuity 4 4
Material Erosion 4 4
Operating System Becomes Nonfunctional 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Power Problem 4 4
Optical Problem 4 4
Noise, Audible 4 4
Patient Device Interaction Problem 4 4
Poor Visibility 4 4
Unexpected Shutdown 3 3
Firing Problem 3 3
Positioning Problem 3 3
Mechanics Altered 3 3
Calibration Problem 3 3
Failure to Fire 3 3
Failure to Calibrate 3 3
Failure to Deliver Energy 3 3
Fire 3 3
Product Quality Problem 3 3
Self-Activation or Keying 3 3
Problem with Sterilization 2 2
Failure to Power Up 2 2
Decrease in Pressure 2 2
Output above Specifications 2 2
Loose or Intermittent Connection 2 2
Filling Problem 2 2
Unstable 2 2
Capturing Problem 2 2
Computer Operating System Problem 2 2
Device Handling Problem 2 2
Activation Failure 1 1
Intermittent Energy Output 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Output below Specifications 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Device Fell 1 1
Intermittent Loss of Power 1 1
Data Problem 1 1
Difficult to Advance 1 1
Failure to Shut Off 1 1
Communication or Transmission Problem 1 1
Application Program Problem 1 1
Blocked Connection 1 1
Optical Discoloration 1 1
Inappropriate or Unexpected Reset 1 1
Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Improper Flow or Infusion 1 1
Suction Problem 1 1
Visual Prompts will not Clear 1 1
Microbial Contamination of Device 1 1
Component Missing 1 1
Inaccurate Delivery 1 1
Fumes or Vapors 1 1
Malposition of Device 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Decrease in Suction 1 1
Deflation Problem 1 1
Display or Visual Feedback Problem 1 1
Break 1 1
Circuit Failure 1 1
Device Reprocessing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 414 414
Keratitis 409 409
Visual Impairment 402 402
Pain 188 188
No Code Available 182 182
Dry Eye(s) 181 181
No Known Impact Or Consequence To Patient 153 153
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 148 148
Visual Disturbances 126 126
Halo 117 117
Discomfort 83 83
Increased Sensitivity 74 74
Foreign Body Sensation in Eye 73 73
Corneal Clouding/Hazing 64 64
Insufficient Information 62 62
Uveitis 61 61
Inflammation 59 59
No Clinical Signs, Symptoms or Conditions 59 59
Eye Pain 59 59
Vitreous Floaters 55 55
Irritation 51 51
Corneal Abrasion 48 48
Depression 48 48
Loss of Vision 44 44
Corneal Infiltrates 42 42
Headache 41 41
Therapeutic Response, Decreased 37 37
Red Eye(s) 34 34
Glaucoma 33 33
Therapeutic Effects, Unexpected 32 32
No Consequences Or Impact To Patient 31 31
Burning Sensation 30 30
Erosion 23 23
Anxiety 23 23
Unspecified Eye / Vision Problem 23 23
Suicidal Ideation 20 20
Hypersensitivity/Allergic reaction 20 20
Eye Injury 19 19
Swelling 18 18
Increased Sensitivity 18 18
Impaired Healing 16 16
Corneal Ulcer 15 15
Emotional Changes 14 14
Corneal Scar 13 13
Itching Sensation 13 13
Cataract 12 12
Excessive Tear Production 11 11
Neuralgia 11 11
Corneal Edema 10 10
Edema 10 10
Erythema 9 9
Intraocular Pressure Increased 8 8
Unspecified Infection 8 8
Patient Problem/Medical Problem 8 8
Tissue Breakdown 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Tissue Damage 7 7
Abrasion 6 6
Nerve Damage 5 5
Clouding, Central Corneal 5 5
Reaction 5 5
Sleep Dysfunction 4 4
Vitreous Detachment 4 4
Complaint, Ill-Defined 4 4
Decreased Sensitivity 4 4
Scarring 4 4
Conjunctivitis 4 4
Death 4 4
Iritis 4 4
Fatigue 3 3
Scar Tissue 3 3
Neuropathy 3 3
Retinal Detachment 3 3
Retinal Tear 3 3
Vomiting 3 3
Foreign Body In Patient 3 3
Injury 3 3
Distress 3 3
Weight Changes 3 3
Eye Burn 3 3
Inadequate Pain Relief 3 3
Disability 3 3
Discharge 2 2
Microcysts, Epithelial 2 2
Ulcer 2 2
Unspecified Mental, Emotional or Behavioural Problem 2 2
Corneal Epithelial Microcysts 2 2
Eye Infections 2 2
Unspecified Tissue Injury 2 2
Swelling/ Edema 2 2
No Information 2 2
Dizziness 2 2
UGH (Uveitis-Glaucoma-Hyphema) Syndrome 2 2
Tinnitus 2 2
Staphylococcus Aureus 2 2
Optical Nerve Damage 2 2
Nausea 2 2
Acanthameba Keratitis 2 2
Laceration(s) 2 2

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