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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 7

MDR Year MDR Reports MDR Events
2019 1060 1060
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 79 81

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1503 1505
Patient-Device Incompatibility 76 76
Energy Output Problem 52 52
Therapeutic or Diagnostic Output Failure 48 48
Appropriate Term/Code Not Available 42 42
Insufficient Information 39 39
Improper or Incorrect Procedure or Method 36 36
Overcorrection 34 34
Failure to Capture 31 31
Unexpected Therapeutic Results 26 26
Device Displays Incorrect Message 22 22
Gas/Air Leak 22 22
Incorrect, Inadequate or Imprecise Result or Readings 22 22
Mechanical Problem 19 19
Defective Device 18 18
Output Problem 15 15
Failure to Align 13 13
Use of Device Problem 11 11
Undercorrection 11 11
Computer Software Problem 10 10
Misfire 8 8
Device Sensing Problem 8 8
Computer System Security Problem 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 421 423
Visual Impairment 417 419
Keratitis 410 410
Dry Eye(s) 190 191
Pain 189 189
No Code Available 182 182
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 164 164
No Known Impact Or Consequence To Patient 153 153
Visual Disturbances 128 128
Halo 122 122
Discomfort 84 84
Increased Sensitivity 74 74
Foreign Body Sensation in Eye 73 73
Insufficient Information 69 69
No Clinical Signs, Symptoms or Conditions 65 65
Corneal Clouding/Hazing 64 64
Eye Pain 62 62
Uveitis 61 61
Inflammation 59 59
Vitreous Floaters 57 57
Irritation 51 51
Depression 51 51
Corneal Abrasion 50 50
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
Anxiety 24 24
Suicidal Ideation 23 23
Unspecified Eye / Vision Problem 23 23
Erosion 23 23
Hypersensitivity/Allergic reaction 20 20
Eye Injury 19 19
Swelling 18 18
Increased Sensitivity 18 18
Emotional Changes 16 16
Impaired Healing 16 16
Corneal Ulcer 15 15
Corneal Scar 13 13
Itching Sensation 13 13
Cataract 12 12
Corneal Edema 11 11
Neuralgia 11 11
Excessive Tear Production 11 11
Edema 10 10

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