Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 563 563
2021 263 263
2022 152 152
2023 128 128
2024 104 109
2025 146 147

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 842 846
Patient-Device Incompatibility 52 52
Energy Output Problem 45 45
Failure to Capture 31 31
Therapeutic or Diagnostic Output Failure 27 27
Insufficient Information 22 22
Appropriate Term/Code Not Available 20 20
Gas/Air Leak 19 19
Unexpected Therapeutic Results 18 18
Overcorrection 17 17
Misfire 14 14
Mechanical Problem 12 12
Output Problem 12 12
Undercorrection 11 11
Use of Device Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Failure to Align 10 10
Computer Software Problem 7 7
Computer System Security Problem 7 7
Material Integrity Problem 6 6
Patient Device Interaction Problem 6 6
Material Opacification 6 6
Lack of Effect 6 6
Unintended System Motion 5 5
Device Displays Incorrect Message 4 4
Defective Device 4 4
Operating System Becomes Nonfunctional 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Inadequate Instructions for Non-Healthcare Professional 4 4
Leak/Splash 4 4
Poor Visibility 4 4
Incorrect Interpretation of Signal 4 4
Optical Problem 3 3
Fire 3 3
Product Quality Problem 3 3
Loss of Power 3 3
Electrical /Electronic Property Problem 3 3
Device Emits Odor 3 3
Capturing Problem 2 2
Filling Problem 2 2
Material Erosion 2 2
Device Sensing Problem 2 2
Failure to Sense 2 2
Self-Activation or Keying 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Unexpected Shutdown 2 2
Firing Problem 2 2
Noise, Audible 2 2
Unintended Movement 2 2
Positioning Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 326 330
Blurred Vision 199 201
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 199 202
Keratitis 154 155
Dry Eye(s) 152 153
Visual Disturbances 115 115
Halo 88 88
Insufficient Information 84 84
Pain 75 75
No Clinical Signs, Symptoms or Conditions 75 75
Eye Pain 74 74
No Code Available 68 68
Corneal Clouding/Hazing 68 68
Uveitis 58 58
Vitreous Floaters 51 51
No Known Impact Or Consequence To Patient 47 47
Depression 43 43
Glaucoma 33 33
Inflammation 32 32
Headache 30 30
Suicidal Ideation 27 27
Loss of Vision 26 26
Red Eye(s) 26 26
Foreign Body Sensation in Eye 25 25
Unspecified Eye / Vision Problem 25 25
Anxiety 23 23
Discomfort 22 22
Burning Sensation 21 21
Increased Sensitivity 21 21
Increased Sensitivity 21 21
Corneal Abrasion 18 18
Emotional Changes 17 17
Eye Injury 16 16
Corneal Infiltrates 16 16
Therapeutic Response, Decreased 16 16
Corneal Scar 12 12
Neuralgia 12 12
Irritation 11 11
Cataract 10 10
Intraocular Pressure Increased 9 9
Therapeutic Effects, Unexpected 9 9
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
Itching Sensation 6 6
Impaired Healing 6 6
Corneal Edema 6 6
Unspecified Mental, Emotional or Behavioural Problem 6 6
Nerve Damage 5 5

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