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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
3 3 6 6 14 18 14 4 10 11 13 6 7 0 8 5

MDR Year MDR Reports MDR Events
2014 1802 1802
2015 1146 1146
2016 808 808
2017 1359 1359
2018 1601 1601
2019 1060 1060
2020 563 563
2021 263 263
2022 152 152
2023 128 128
2024 37 37

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5207 5207
Insufficient Information 1288 1288
Device Operates Differently Than Expected 455 455
Device Displays Incorrect Message 238 238
Appropriate Term/Code Not Available 192 192
Improper or Incorrect Procedure or Method 176 176
Patient-Device Incompatibility 167 167
Overcorrection 138 138
Unexpected Therapeutic Results 134 134
Energy Output Problem 88 88
Therapeutic or Diagnostic Output Failure 76 76
Device Inoperable 50 50
Gas/Air Leak 49 49
Failure to Align 41 41
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Use of Device Problem 38 38
Failure to Capture 33 33
Output Problem 31 31
Unintended Movement 31 31
Defective Device 29 29
Device Emits Odor 27 27
Mechanical Problem 27 27
Computer Software Problem 23 23
Use of Incorrect Control/Treatment Settings 22 22
Device Sensing Problem 22 22
Electrical /Electronic Property Problem 17 17
Output below Specifications 16 16
Loss of Power 13 13
Failure to Cut 13 13
Failure to Fire 12 12
Loose or Intermittent Connection 12 12
Output above Specifications 12 12
Calibration Problem 11 11
Malposition of Device 11 11
Suction Problem 11 11
Undercorrection 11 11
Unstable 10 10
Device Operational Issue 10 10
Incorrect Measurement 10 10
Leak/Splash 10 10
Defective Component 9 9
Power Problem 9 9
Material Integrity Problem 9 9
Noise, Audible 9 9
Optical Problem 8 8
Positioning Problem 8 8
Device Stops Intermittently 8 8
Misfire 8 8
Improper Device Output 8 8
Energy Output To Patient Tissue Incorrect 8 8
Material Opacification 8 8
Device Alarm System 8 8
Failure to Deliver Energy 8 8
Material Erosion 7 7
Unintended System Motion 7 7
Computer System Security Problem 7 7
Smoking 7 7
Failure to Power Up 6 6
Self-Activation or Keying 6 6
Intermittent Continuity 6 6
Display or Visual Feedback Problem 6 6
Application Interface Becomes Non-Functional Or Program Exits Abnormally 6 6
Lack of Effect 6 6
Programming Issue 5 5
Protective Measures Problem 5 5
Operating System Becomes Nonfunctional 5 5
Decrease in Suction 5 5
Signal Artifact/Noise 5 5
Air Leak 5 5
Visual Prompts will not Clear 5 5
Inadequate Instructions for Non-Healthcare Professional 5 5
Inappropriate or Unexpected Reset 4 4
Computer Operating System Problem 4 4
Vibration 4 4
Failure to Calibrate 4 4
Fumes or Vapors 4 4
Fire 4 4
Failure to Sense 4 4
Device Slipped 4 4
Power Conditioning Problem 4 4
Misfocusing 4 4
Energy Spectrum Incorrect 4 4
Patient Device Interaction Problem 4 4
Firing Problem 4 4
Data Problem 4 4
Poor Visibility 4 4
Device Handling Problem 4 4
Torn Material 3 3
Unexpected Shutdown 3 3
Mechanics Altered 3 3
Reset Problem 3 3
No Device Output 3 3
Inadequacy of Device Shape and/or Size 3 3
Product Quality Problem 3 3
False Reading From Device Non-Compliance 3 3
Break 3 3
Thermal Decomposition of Device 3 3
Defective Alarm 3 3
Device Reprocessing Problem 3 3
Detachment Of Device Component 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Blurred Vision 1808 1808
Keratitis 1791 1791
No Code Available 1688 1688
Dry Eye(s) 1123 1123
Visual Impairment 1109 1110
No Known Impact Or Consequence To Patient 648 648
Pain 643 643
Visual Disturbances 382 382
Corneal Clouding/Hazing 365 365
Increased Sensitivity 356 356
Halo 308 309
Foreign Body Sensation in Eye 301 301
Inflammation 293 293
Discomfort 279 279
Irritation 253 253
Corneal Abrasion 208 208
No Consequences Or Impact To Patient 184 185
Loss of Vision 163 163
Erosion 160 160
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 151 151
Headache 147 147
Complaint, Ill-Defined 135 135
Burning Sensation 131 131
Red Eye(s) 127 128
Corneal Infiltrates 111 111
Therapeutic Effects, Unexpected 109 109
Eye Injury 95 95
Excessive Tear Production 91 91
No Information 91 91
Vitreous Floaters 90 90
Hypersensitivity/Allergic reaction 89 89
Uveitis 89 89
Depression 86 86
Therapeutic Response, Decreased 65 65
Impaired Healing 64 64
Insufficient Information 64 64
Postoperative refraction, unexpected 63 63
Itching Sensation 63 64
No Clinical Signs, Symptoms or Conditions 61 61
Eye Pain 60 60
Corneal Edema 56 56
Swelling 56 56
Unspecified Infection 49 49
Anxiety 48 48
Corneal Ulcer 41 41
Overcorrection 39 39
Patient Problem/Medical Problem 39 39
Glaucoma 37 37
Intraocular Pressure Increased 34 34
Reaction 33 33
Edema 31 31
Emotional Changes 30 30
Cataract 29 29
Erythema 27 27
Unspecified Eye / Vision Problem 23 23
Corneal Scar 21 21
Phototoxicity 21 21
Retinal Detachment 20 20
Iritis 20 20
Suicidal Ideation 20 20
Other (for use when an appropriate patient code cannot be identified) 19 19
Conjunctivitis 18 18
Increased Sensitivity 18 18
Foreign Body In Patient 17 17
Abrasion 17 17
Nausea 17 17
Scarring 16 16
Dizziness 15 15
Injury 15 15
Disability 15 15
Vitreous Detachment 14 14
Discharge 14 14
Bacterial Infection 14 15
Fatigue 12 12
Diplopia 12 12
No Patient Involvement 11 11
Wrinkling 11 11
Neuralgia 11 11
Acanthameba Keratitis 11 11
Cataract, Induced 11 11
Microcysts, Epithelial 10 10
Tissue Damage 10 10
Death 8 8
Nerve Damage 8 8
Hemorrhage/Bleeding 8 8
Sleep Dysfunction 8 8
Tissue Breakdown 7 7
Toxic Anterior Segment Syndrome (TASS) 7 7
UGH (Uveitis Glaucoma Hyphema) Syndrome 7 7
Infiltration into Tissue 7 7
Retinal Tear 7 7
Inadequate Pain Relief 7 7
Clouding, Central Corneal 6 6
Optical Nerve Damage 6 6
Ulcer 6 6
Decreased Sensitivity 5 5
Vomiting 5 5
Staphylococcus Aureus 5 5
Viral Infection 5 5
Irritability 4 4

Recalls
Manufacturer Recall Class Date Posted
1 AMO Manufacturing USA, LLC II Dec-29-2021
2 AMO Manufacturing USA, LLC II Aug-09-2011
3 AMO Manufacturing USA, LLC II Feb-18-2011
4 Abbott Medical Optics, Inc. II Oct-22-2013
5 Abbott Medical Optics, Inc. II Jun-13-2013
6 Nidek Inc II Mar-20-2017
7 Nidek Inc II Jun-04-2015
8 Nidek Inc II Nov-17-2014
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