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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 260 261

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 928 934
Patient-Device Incompatibility 58 58
Energy Output Problem 48 48
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 15 15
Patient Device Interaction Problem 14 14
Mechanical Problem 13 13
Output Problem 13 13
Use of Device Problem 13 13
Undercorrection 11 11
Failure to Align 10 10
Computer Software Problem 9 9
Computer System Security Problem 7 7
Material Opacification 6 6
Incorrect Interpretation of Signal 6 6
Material Integrity Problem 6 6
Lack of Effect 6 6
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
Unexpected Shutdown 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
Material Erosion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 361 366
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 229 232
Blurred Vision 216 220
Dry Eye(s) 171 172
Keratitis 156 157
Visual Disturbances 125 126
Halo 99 101
Insufficient Information 91 91
Eye Pain 86 87
No Clinical Signs, Symptoms or Conditions 81 81
Pain 79 79
Corneal Clouding/Hazing 75 75
No Code Available 68 69
Uveitis 58 58
Vitreous Floaters 53 53
Depression 47 47
No Known Impact Or Consequence To Patient 47 47
Inflammation 38 38
Glaucoma 33 33
Headache 32 32
Suicidal Ideation 30 30
Unspecified Eye / Vision Problem 30 32
Anxiety 28 28
Red Eye(s) 27 27
Loss of Vision 27 27
Foreign Body Sensation in Eye 25 25
Discomfort 25 25
Increased Sensitivity 24 24
Burning Sensation 23 23
Emotional Changes 23 23
Increased Sensitivity 22 22
Eye Injury 21 21
Corneal Abrasion 21 21
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
Itching Sensation 8 8
Corneal Ulcer 8 8
No Consequences Or Impact To Patient 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Corneal Edema 7 7
Impaired Healing 7 7
Nerve Damage 6 6
Unspecified Mental, Emotional or Behavioural Problem 6 6

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