• 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 femtosecond laser system for refractive correction
Definition Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
Product CodeOTL
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
3 2 2 2 5 0

MDR Year MDR Reports MDR Events
2020 7 7
2021 6 6
2022 3 3
2023 13 13
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 9 9
Insufficient Information 7 7
Device Handling Problem 2 2
Optical Obstruction 2 2
Contamination 2 2
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Device Fell 2 2
Improper or Incorrect Procedure or Method 2 2
Lack of Effect 1 1
Off-Label Use 1 1
Calibration Problem 1 1
Unintended Movement 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Visual Impairment 21 21
Dry Eye(s) 12 12
Halo 9 9
Depression 7 7
Suicidal Ideation 5 5
Eye Pain 5 5
Pain 5 5
Loss of Vision 5 5
Vitreous Floaters 4 4
Discomfort 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Eye / Vision Problem 3 3
Anxiety 2 2
Corneal Edema 2 2
Emotional Changes 2 2
Eye Injury 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Keratitis 2 2
Nerve Damage 2 2
Blurred Vision 2 2
Visual Disturbances 2 2
Corneal Scar 1 1
Flashers 1 1
Headache 1 1
Increased Sensitivity 1 1
Neuralgia 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1

-
-