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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 2026
6 7 0 8 10 6 1

MDR Year MDR Reports MDR Events
2020 565 566
2021 266 267
2022 152 153
2023 128 128
2024 104 109
2025 280 281
2026 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 952 958
Patient-Device Incompatibility 60 60
Energy Output Problem 50 50
Gas/Air Leak 34 34
Failure to Capture 31 31
Therapeutic or Diagnostic Output Failure 31 31
Insufficient Information 24 24
Unexpected Therapeutic Results 23 23
Appropriate Term/Code Not Available 20 21
Overcorrection 17 17
Improper or Incorrect Procedure or Method 16 16
Patient Device Interaction Problem 16 16
Misfire 15 15
Output Problem 14 14
Use of Device Problem 13 13
Mechanical Problem 13 13
Undercorrection 11 11
Failure to Align 10 10
Computer Software Problem 9 9
Incorrect Interpretation of Signal 8 8
Computer System Security Problem 7 7
Material Integrity Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Material Opacification 6 6
Unintended System Motion 6 6
Lack of Effect 6 6
Product Quality Problem 5 5
Defective Device 5 5
Device Displays Incorrect Message 4 4
Operating System Becomes Nonfunctional 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Leak/Splash 4 4
Poor Visibility 4 4
Unexpected Shutdown 3 3
Application Program Freezes, Becomes Nonfunctional 3 3
Optical Problem 3 3
Fire 3 3
Electrical /Electronic Property Problem 3 3
Failure to Sense 3 3
Device Emits Odor 3 3
Loss of Power 3 3
Self-Activation or Keying 2 2
Material Erosion 2 2
Filling Problem 2 2
Contamination 2 2
Use of Incorrect Control/Treatment Settings 2 2
Device Sensing Problem 2 2
Material Deformation 2 2
Positioning Problem 2 2
Capturing Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 372 377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 242 245
Blurred Vision 222 226
Dry Eye(s) 180 181
Keratitis 158 159
Visual Disturbances 130 131
Halo 100 102
Insufficient Information 98 98
Eye Pain 93 94
No Clinical Signs, Symptoms or Conditions 86 86
Pain 80 80
Corneal Clouding/Hazing 77 77
No Code Available 68 69
Uveitis 58 58
Vitreous Floaters 53 53
Depression 49 49
No Known Impact Or Consequence To Patient 47 47
Inflammation 38 38
Headache 33 33
Glaucoma 33 33
Suicidal Ideation 32 32
Anxiety 31 31
Unspecified Eye / Vision Problem 31 33
Discomfort 27 27
Loss of Vision 27 27
Red Eye(s) 27 27
Foreign Body Sensation in Eye 25 25
Corneal Abrasion 24 24
Increased Sensitivity 24 24
Emotional Changes 23 23
Burning Sensation 23 23
Increased Sensitivity 22 22
Eye Injury 21 21
Therapeutic Response, Decreased 16 16
Corneal Infiltrates 16 16
Neuralgia 13 13
Corneal Scar 12 12
Irritation 11 11
Cataract 10 11
Unspecified Respiratory Problem 10 10
Intraocular Pressure Increased 9 9
Corneal Edema 9 9
Therapeutic Effects, Unexpected 9 9
Corneal Ulcer 9 9
Itching Sensation 8 8
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
No Consequences Or Impact To Patient 7 7
Impaired Healing 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
Hypersensitivity/Allergic reaction 6 6

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