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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 1

MDR Year MDR Reports MDR Events
2021 266 267
2022 152 153
2023 128 128
2024 104 109
2025 280 281
2026 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 573 578
Patient-Device Incompatibility 50 50
Energy Output Problem 38 38
Failure to Capture 31 31
Gas/Air Leak 30 30
Insufficient Information 18 18
Patient Device Interaction Problem 16 16
Unexpected Therapeutic Results 15 15
Misfire 15 15
Appropriate Term/Code Not Available 12 13
Therapeutic or Diagnostic Output Failure 12 12
Use of Device Problem 11 11
Failure to Align 10 10
Improper or Incorrect Procedure or Method 9 9
Output Problem 9 9
Computer Software Problem 9 9
Incorrect Interpretation of Signal 8 8
Mechanical Problem 8 8
Computer System Security Problem 7 7
Lack of Effect 6 6
Unintended System Motion 4 4
Product Quality Problem 4 4
Poor Visibility 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Contamination 3 3
Failure to Sense 3 3
Fire 3 3
Unexpected Shutdown 3 3
Operating System Becomes Nonfunctional 3 3
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Defective Device 2 2
Material Deformation 2 2
Filling Problem 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Capturing Problem 2 2
Noise, Audible 2 2
Defective Component 1 1
Decrease in Suction 1 1
Environmental Compatibility Problem 1 2
Use of Incorrect Control/Treatment Settings 1 1
Optical Problem 1 1
Data Problem 1 1
Application Program Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Sensing Problem 1 1
Break 1 1
Failure to Calibrate 1 1
Compatibility Problem 1 1
Failure to Shut Off 1 1
Intermittent Continuity 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 298 303
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 223 226
Dry Eye(s) 153 154
Blurred Vision 143 147
Visual Disturbances 92 92
Eye Pain 92 93
Keratitis 84 85
Halo 76 77
No Clinical Signs, Symptoms or Conditions 76 76
Insufficient Information 74 74
Corneal Clouding/Hazing 53 53
Vitreous Floaters 45 45
Depression 45 45
Pain 35 35
Suicidal Ideation 32 32
Unspecified Eye / Vision Problem 30 32
Anxiety 28 28
Headache 27 27
Loss of Vision 22 22
Emotional Changes 21 21
Increased Sensitivity 20 20
Corneal Abrasion 18 18
Discomfort 16 16
Eye Injury 15 15
Inflammation 15 15
Neuralgia 13 13
Burning Sensation 10 10
Unspecified Respiratory Problem 10 10
Cataract 9 10
Foreign Body Sensation in Eye 9 9
Red Eye(s) 8 8
Corneal Scar 6 6
Unspecified Mental, Emotional or Behavioural Problem 6 6
Corneal Edema 6 6
Swelling/ Edema 4 4
Itching Sensation 4 4
Vitreous Detachment 4 4
Nerve Damage 4 4
Erosion 4 4
Eye Infections 4 4
Impaired Healing 4 4
Neuropathy 4 4
Vomiting 3 3
Retinal Detachment 3 3
Irritation 3 3
Glaucoma 3 3
Inadequate Pain Relief 3 3
Cognitive Changes 3 3
Uveitis 3 3
Dizziness 3 3

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