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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 5

MDR Year MDR Reports MDR Events
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 104 109
2025 42 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 761 765
Patient-Device Incompatibility 51 51
Energy Output Problem 45 45
Failure to Capture 31 31
Therapeutic or Diagnostic Output Failure 26 26
Insufficient Information 22 22
Appropriate Term/Code Not Available 20 20
Gas/Air Leak 18 18
Overcorrection 17 17
Unexpected Therapeutic Results 13 13
Mechanical Problem 12 12
Undercorrection 11 11
Output Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Align 10 10
Use of Device Problem 10 10
Misfire 9 9
Computer System Security Problem 7 7
Computer Software Problem 7 7
Material Opacification 6 6
Lack of Effect 6 6
Material Integrity Problem 6 6
Unintended System Motion 5 5
Device Displays Incorrect Message 4 4
Incorrect Interpretation of Signal 4 4
Poor Visibility 4 4
Patient Device Interaction Problem 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Leak/Splash 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Defective Device 4 4
Operating System Becomes Nonfunctional 4 4
Loss of Power 3 3
Electrical /Electronic Property Problem 3 3
Product Quality Problem 3 3
Device Emits Odor 3 3
Fire 3 3
Optical Problem 3 3
Noise, Audible 2 2
Capturing Problem 2 2
Firing Problem 2 2
Self-Activation or Keying 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Unexpected Shutdown 2 2
Device Sensing Problem 2 2
Material Erosion 2 2
Filling Problem 2 2
Unintended Movement 2 2
Failure to Sense 2 2
Positioning Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 316 320
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 180 183
Blurred Vision 163 165
Dry Eye(s) 142 143
Keratitis 123 124
Visual Disturbances 86 86
Halo 84 84
Insufficient Information 80 80
Pain 72 72
Eye Pain 71 71
No Clinical Signs, Symptoms or Conditions 70 70
No Code Available 68 68
Uveitis 58 58
Vitreous Floaters 51 51
No Known Impact Or Consequence To Patient 47 47
Depression 43 43
Corneal Clouding/Hazing 39 39
Glaucoma 33 33
Inflammation 32 32
Headache 29 29
Suicidal Ideation 26 26
Red Eye(s) 26 26
Foreign Body Sensation in Eye 25 25
Unspecified Eye / Vision Problem 25 25
Loss of Vision 25 25
Anxiety 23 23
Discomfort 22 22
Increased Sensitivity 21 21
Increased Sensitivity 21 21
Burning Sensation 20 20
Corneal Abrasion 18 18
Corneal Infiltrates 16 16
Emotional Changes 16 16
Eye Injury 16 16
Therapeutic Response, Decreased 16 16
Neuralgia 12 12
Irritation 11 11
Corneal Scar 10 10
Intraocular Pressure Increased 9 9
Therapeutic Effects, Unexpected 9 9
Corneal Ulcer 8 8
Cataract 8 8
Toxic Anterior Segment Syndrome (TASS) 7 7
No Consequences Or Impact To Patient 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Itching Sensation 6 6
Corneal Edema 6 6
Impaired Healing 6 6
Edema 5 5
Erosion 5 5

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