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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)
2020 2021 2022 2023 2024 2025
6 7 0 8 10 6

MDR Year MDR Reports MDR Events
2020 565 566
2021 266 267
2022 152 153
2023 128 128
2024 104 109
2025 218 219

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 894 900
Patient-Device Incompatibility 57 57
Energy Output Problem 46 46
Failure to Capture 31 31
Therapeutic or Diagnostic Output Failure 30 30
Insufficient Information 23 23
Gas/Air Leak 22 22
Unexpected Therapeutic Results 21 21
Appropriate Term/Code Not Available 20 21
Overcorrection 17 17
Improper or Incorrect Procedure or Method 16 16
Misfire 14 14
Output Problem 13 13
Use of Device Problem 13 13
Mechanical Problem 12 12
Patient Device Interaction Problem 12 12
Undercorrection 11 11
Failure to Align 10 10
Computer Software Problem 8 8
Computer System Security Problem 7 7
Material Opacification 6 6
Material Integrity Problem 6 6
Lack of Effect 6 6
Incorrect Interpretation of Signal 5 5
Unintended System Motion 5 5
Defective Device 5 5
Leak/Splash 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Device Displays Incorrect Message 4 4
Operating System Becomes Nonfunctional 4 4
Poor Visibility 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Loss of Power 3 3
Electrical /Electronic Property Problem 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Product Quality Problem 3 3
Device Emits Odor 3 3
Optical Problem 3 3
Fire 3 3
Noise, Audible 2 2
Capturing Problem 2 2
Positioning Problem 2 2
Firing Problem 2 2
Failure to Sense 2 2
Unintended Movement 2 2
Device Sensing Problem 2 2
Self-Activation or Keying 2 2
Filling Problem 2 2
Unexpected Shutdown 2 2
Material Erosion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 345 350
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 223 226
Blurred Vision 208 212
Dry Eye(s) 167 168
Keratitis 155 156
Visual Disturbances 124 125
Halo 97 99
Insufficient Information 88 88
Eye Pain 85 86
Pain 79 79
No Clinical Signs, Symptoms or Conditions 79 79
Corneal Clouding/Hazing 73 73
No Code Available 68 69
Uveitis 58 58
Vitreous Floaters 53 53
No Known Impact Or Consequence To Patient 47 47
Depression 46 46
Inflammation 38 38
Glaucoma 33 33
Headache 32 32
Suicidal Ideation 30 30
Unspecified Eye / Vision Problem 29 31
Loss of Vision 27 27
Anxiety 27 27
Red Eye(s) 27 27
Foreign Body Sensation in Eye 25 25
Increased Sensitivity 24 24
Discomfort 24 24
Burning Sensation 23 23
Emotional Changes 23 23
Increased Sensitivity 22 22
Corneal Abrasion 21 21
Eye Injury 19 19
Corneal Infiltrates 16 16
Therapeutic Response, Decreased 16 16
Neuralgia 13 13
Corneal Scar 12 12
Irritation 11 11
Cataract 10 11
Therapeutic Effects, Unexpected 9 9
Intraocular Pressure Increased 9 9
Corneal Ulcer 8 8
Itching Sensation 8 8
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
No Consequences Or Impact To Patient 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
Impaired Healing 7 7
Hypersensitivity/Allergic reaction 6 6
Corneal Edema 6 6
Nerve Damage 6 6

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