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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 4

MDR Year MDR Reports MDR Events
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 104 109
2025 14 15

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 756 760
Patient-Device Incompatibility 50 50
Energy Output Problem 44 44
Failure to Capture 31 31
Therapeutic or Diagnostic Output Failure 25 25
Insufficient Information 22 22
Appropriate Term/Code Not Available 20 20
Gas/Air Leak 18 18
Overcorrection 17 17
Mechanical Problem 12 12
Unexpected Therapeutic Results 11 11
Output Problem 11 11
Undercorrection 11 11
Improper or Incorrect Procedure or Method 10 10
Failure to Align 10 10
Use of Device Problem 9 9
Misfire 8 8
Computer System Security Problem 7 7
Computer Software Problem 7 7
Material Integrity Problem 6 6
Lack of Effect 6 6
Material Opacification 6 6
Unintended System Motion 5 5
Leak/Splash 4 4
Defective Device 4 4
Patient Device Interaction Problem 4 4
Poor Visibility 4 4
Operating System Becomes Nonfunctional 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Device Displays Incorrect Message 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Product Quality Problem 3 3
Electrical /Electronic Property Problem 3 3
Fire 3 3
Optical Problem 3 3
Incorrect Interpretation of Signal 3 3
Device Emits Odor 3 3
Loss of Power 3 3
Noise, Audible 2 2
Device Sensing Problem 2 2
Firing Problem 2 2
Failure to Sense 2 2
Filling Problem 2 2
Unintended Movement 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Capturing Problem 2 2
Material Erosion 2 2
Positioning Problem 2 2
Self-Activation or Keying 2 2
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 306 310
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 174 177
Blurred Vision 158 160
Dry Eye(s) 133 134
Keratitis 123 124
Visual Disturbances 81 81
Insufficient Information 79 79
Halo 78 78
Pain 70 70
No Code Available 68 68
Eye Pain 66 66
No Clinical Signs, Symptoms or Conditions 65 65
Uveitis 58 58
Vitreous Floaters 48 48
No Known Impact Or Consequence To Patient 47 47
Depression 41 41
Corneal Clouding/Hazing 38 38
Glaucoma 33 33
Inflammation 32 32
Headache 27 27
Red Eye(s) 25 25
Foreign Body Sensation in Eye 25 25
Suicidal Ideation 24 24
Loss of Vision 24 24
Unspecified Eye / Vision Problem 24 24
Discomfort 22 22
Increased Sensitivity 21 21
Anxiety 21 21
Burning Sensation 20 20
Increased Sensitivity 18 18
Corneal Abrasion 18 18
Corneal Infiltrates 16 16
Therapeutic Response, Decreased 16 16
Eye Injury 16 16
Emotional Changes 15 15
Neuralgia 11 11
Irritation 11 11
Therapeutic Effects, Unexpected 9 9
Corneal Scar 9 9
Intraocular Pressure Increased 9 9
Cataract 8 8
Corneal Ulcer 8 8
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
No Consequences Or Impact To Patient 7 7
Corneal Edema 6 6
Itching Sensation 6 6
Erosion 5 5
Nerve Damage 5 5
Impaired Healing 5 5

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