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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 2024
11 13 6 7 0 8 7

MDR Year MDR Reports MDR Events
2018 1601 1601
2019 1060 1060
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 70 72

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2346 2348
Insufficient Information 278 278
Patient-Device Incompatibility 115 115
Appropriate Term/Code Not Available 100 100
Improper or Incorrect Procedure or Method 89 89
Device Operates Differently Than Expected 76 76
Unexpected Therapeutic Results 75 75
Overcorrection 69 69
Device Displays Incorrect Message 67 67
Energy Output Problem 61 61
Therapeutic or Diagnostic Output Failure 49 49
Incorrect, Inadequate or Imprecise Result or Readings 38 38
Gas/Air Leak 34 34
Failure to Capture 31 31
Defective Device 27 27
Mechanical Problem 24 24
Output Problem 20 20
Computer Software Problem 19 19
Failure to Align 17 17
Device Sensing Problem 16 16
Use of Device Problem 15 15
Device Emits Odor 15 15
Electrical /Electronic Property Problem 11 11
Undercorrection 11 11
Material Integrity Problem 9 9
Misfire 8 8
Computer System Security Problem 7 7
Device Inoperable 7 7
Power Problem 7 7
Optical Problem 7 7
Incorrect Measurement 7 7
Unintended Movement 7 7
Material Opacification 7 7
Leak/Splash 7 7
Loose or Intermittent Connection 7 7
Material Erosion 6 6
Noise, Audible 6 6
Output above Specifications 6 6
Lack of Effect 6 6
Defective Component 6 6
Calibration Problem 6 6
Loss of Power 5 5
Intermittent Continuity 5 5
Device Alarm System 5 5
Self-Activation or Keying 5 5
Protective Measures Problem 5 5
Unintended System Motion 5 5
Display or Visual Feedback Problem 4 4
Inappropriate or Unexpected Reset 4 4
Patient Device Interaction Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Keratitis 816 816
Blurred Vision 768 770
Visual Impairment 612 615
No Code Available 409 409
Dry Eye(s) 327 328
No Known Impact Or Consequence To Patient 322 322
Pain 301 301
Halo 178 179
Increased Sensitivity 172 172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 161 161
Visual Disturbances 159 159
Foreign Body Sensation in Eye 138 138
Discomfort 136 136
Inflammation 103 103
Corneal Clouding/Hazing 97 97
Irritation 89 89
Corneal Abrasion 82 82
Erosion 76 76
Loss of Vision 70 70
Insufficient Information 67 67
Uveitis 67 67
Headache 66 66
Corneal Infiltrates 65 65
Vitreous Floaters 65 65
No Clinical Signs, Symptoms or Conditions 64 64
Eye Pain 62 62
Depression 61 61
Burning Sensation 61 61
Red Eye(s) 55 56
Therapeutic Effects, Unexpected 50 50
No Consequences Or Impact To Patient 48 48
Therapeutic Response, Decreased 40 40
Impaired Healing 38 38
Glaucoma 36 36
Eye Injury 35 35
Hypersensitivity/Allergic reaction 34 34
Anxiety 30 30
Swelling 28 28
Itching Sensation 27 28
Excessive Tear Production 27 27
Patient Problem/Medical Problem 26 26
Complaint, Ill-Defined 24 24
Corneal Ulcer 23 23
Emotional Changes 23 23
Suicidal Ideation 23 23
Unspecified Eye / Vision Problem 23 23
No Information 21 21
Corneal Edema 20 20
Unspecified Infection 18 18
Increased Sensitivity 18 18

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