• 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 laser, ophthalmic
Regulation Description Ophthalmic laser.
Product CodeHQF
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
BEAVER-VISITEC INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BELKIN VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC AG
  SUBSTANTIALLY EQUIVALENT 1
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
ELLEX MEDICAL PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LUMENIS BE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 2
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NORLASE
  SUBSTANTIALLY EQUIVALENT 1
NORLASE APS
  SUBSTANTIALLY EQUIVALENT 2
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 72 72
2021 100 100
2022 111 111
2023 92 92
2024 75 75
2025 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 187 187
Adverse Event Without Identified Device or Use Problem 72 72
Appropriate Term/Code Not Available 43 43
Failure to Deliver Energy 27 27
Failure to Fire 25 25
Unexpected Shutdown 14 14
Intermittent Energy Output 10 10
Power Problem 10 10
Use of Device Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Loss of Power 8 8
Unexpected Therapeutic Results 8 8
Insufficient Information 7 7
Electrical /Electronic Property Problem 6 6
Firing Problem 6 6
Break 4 4
No Display/Image 4 4
Device Operational Issue 4 4
Output Problem 4 4
Defective Component 4 4
Output below Specifications 3 3
Misfocusing 3 3
Display or Visual Feedback Problem 3 3
Self-Activation or Keying 3 3
Contamination /Decontamination Problem 3 3
Patient-Device Incompatibility 3 3
Failure to Align 2 2
Defective Device 2 2
Device Handling Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Noise, Audible 2 2
Key or Button Unresponsive/not Working 1 1
Misfire 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Program or Algorithm Execution Problem 1 1
Positioning Problem 1 1
Component Missing 1 1
Energy Spectrum Incorrect 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Material Separation 1 1
Expiration Date Error 1 1
Device Contamination with Chemical or Other Material 1 1
Component Misassembled 1 1
Smoking 1 1
Device Fell 1 1
Connection Problem 1 1
Complete Loss of Power 1 1
Image Display Error/Artifact 1 1
Inappropriate or Unexpected Reset 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 238 238
Insufficient Information 70 70
Eye Burn 39 39
No Known Impact Or Consequence To Patient 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Eye Injury 14 14
No Consequences Or Impact To Patient 13 13
Intraocular Pressure Increased 10 10
Blurred Vision 8 8
Visual Impairment 8 8
Inflammation 7 7
Superficial (First Degree) Burn 6 6
Eye Pain 6 6
No Code Available 5 5
Loss of Vision 5 5
Hemorrhage/Bleeding 5 5
Keratitis 4 4
No Patient Involvement 4 4
Corneal Edema 4 4
Unspecified Eye / Vision Problem 3 3
Vitreous Hemorrhage 3 3
Corneal Clouding/Hazing 2 2
Iritis 2 2
Electric Shock 2 2
Cataract 2 2
Intraocular Pressure Decreased 2 2
Retinal Injury 2 2
Burn(s) 2 2
Pain 2 2
Vitreous Floaters 2 2
Uveitis 1 1
Hyperemia 1 1
Headache 1 1
Partial thickness (Second Degree) Burn 1 1
Tissue Damage 1 1
Swelling/ Edema 1 1
Eye Infections 1 1
Scar Tissue 1 1
Nerve Damage 1 1
Burning Sensation 1 1
Flashers 1 1
Cardiac Arrest 1 1
Heart Failure 1 1
Perforation 1 1
Dry Eye(s) 1 1
Radiation Exposure, Unintended 1 1
Red Eye(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dutch Ophthalmic USA, Inc. II Jul-20-2021
2 Ellex Medical Pty Ltd. II Jun-27-2023
-
-