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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)
2021 2022 2023 2024 2025 2026
7 0 8 10 6 2

MDR Year MDR Reports MDR Events
2021 266 267
2022 152 153
2023 128 128
2024 104 109
2025 280 281
2026 65 68

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 490 495
Energy Output Problem 38 38
Gas/Air Leak 31 31
Failure to Capture 31 31
Insufficient Device Problem Information 16 16
Misfire 15 15
Unexpected Therapeutic Results 13 13
Appropriate Device Problem Term/Code Not Available 12 14
Failure to Align 10 10
Computer Software Problem 9 9
Incorrect Interpretation of Signal 9 9
Mechanical Problem 8 8
Computer System Security Problem 6 6
Poor Visibility 4 4
Unintended System Motion 4 4
Operating System Becomes Nonfunctional 3 3
Unexpected Shutdown 3 3
Fire 3 3
Failure to Sense 3 3
Contamination 3 3
Filling Problem 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Application Program Freezes or Fails to Launch 2 2
Product Quality Problem 2 2
Capturing Problem 2 2
Noise, Audible 2 2
Failure to Shut Off 1 1
Defective Component 1 1
Decrease in Suction 1 1
Environmental Compatibility Problem 1 2
Optical Problem 1 1
Failure to Calibrate 1 1
Intermittent Continuity 1 1
Failure to Cycle 1 1
Undercorrection 1 1
Firing Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 312 318
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 224 227
Dry Eye(s) 157 160
Blurred Vision 146 150
Visual Disturbances 94 94
Eye Pain 93 94
Keratitis 81 84
No Clinical Signs, Symptoms or Conditions 79 79
Halo 76 77
Insufficient Information 75 75
Corneal Clouding/Hazing 54 54
Depression 45 45
Vitreous Floaters 45 45
Pain 35 35
Suicidal Ideation 33 33
Unspecified Eye / Vision Problem 30 32
Diplopia/Double Vision 28 28
Anxiety 28 28
Headache 27 27
Loss of Vision 22 22
Emotional Changes 21 21
Hyperresponsive to stimuli 20 20
Corneal Abrasion 20 20
Discomfort 16 16
Inflammation 15 15
Eye Injury 15 15
Neuralgia 14 14
Eye Irritation 12 12
Unspecified Respiratory Problem 10 10
Burning Sensation 10 10
Cataract 9 10
Photophobia 9 9
Foreign Body Sensation in Eye 9 9
Corneal Thinning 8 8
Red Eye(s) 8 8
Corneal Edema 6 6
Corneal Scar 6 6
Unspecified Mental, Emotional or Behavioural Problem 6 6
Eye Infections 4 4
Swelling/ Edema 4 4
Erosion 4 4
Nerve Damage 4 4
Neuropathy 4 4
Impaired Healing 4 4
Itching Sensation 4 4
Vitreous Detachment 4 4
Glaucoma 3 3
Irritation 3 3
Corneal Infiltrates 3 3
Uveitis 3 3

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