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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device laser, ophthalmic
Product CodeHQF
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
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
LIGHT-MED(USA), INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS BE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 2
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NORLASE
  SUBSTANTIALLY EQUIVALENT 1
NORLASE APS
  SUBSTANTIALLY EQUIVALENT 2
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 66 66
2020 72 72
2021 100 100
2022 111 111
2023 92 92
2024 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 169 169
Adverse Event Without Identified Device or Use Problem 56 56
Appropriate Term/Code Not Available 44 44
Power Problem 24 24
Failure to Deliver Energy 19 19
Failure to Fire 16 16
Unexpected Shutdown 15 15
Intermittent Energy Output 10 10
Therapeutic or Diagnostic Output Failure 10 10
Electrical /Electronic Property Problem 10 10
Unexpected Therapeutic Results 8 8
Use of Device Problem 7 7
Output Problem 7 7
Insufficient Information 6 6
Defective Component 6 6
Self-Activation or Keying 6 6
Break 6 6
Loss of Power 6 6
Firing Problem 5 5
Inappropriate or Unexpected Reset 4 4
Output below Specifications 4 4
Device Operational Issue 4 4
No Display/Image 4 4
Display or Visual Feedback Problem 4 4
Misfocusing 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Component Missing 2 2
Failure to Align 2 2
Improper or Incorrect Procedure or Method 2 2
Failure to Power Up 2 2
Connection Problem 2 2
Intermittent Loss of Power 2 2
Device Handling Problem 2 2
Noise, Audible 2 2
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Program or Algorithm Execution Problem 1 1
Incomplete or Inadequate Connection 1 1
Key or Button Unresponsive/not Working 1 1
Device Fell 1 1
Complete Loss of Power 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Operating System Becomes Nonfunctional 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate User Interface 1 1
Positioning Problem 1 1
Reset Problem 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Device Emits Odor 1 1
Power Conditioning Problem 1 1
Intermittent Continuity 1 1
Crack 1 1
Energy Spectrum Incorrect 1 1
Image Display Error/Artifact 1 1
Fitting Problem 1 1
No Audible Prompt/Feedback 1 1
Expiration Date Error 1 1
Misfire 1 1
Communication or Transmission Problem 1 1
Device Displays Incorrect Message 1 1
Material Separation 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 228 228
No Known Impact Or Consequence To Patient 58 58
Eye Burn 39 39
No Consequences Or Impact To Patient 31 31
Insufficient Information 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Eye Injury 13 13
No Patient Involvement 8 8
Visual Impairment 8 8
Superficial (First Degree) Burn 6 6
No Code Available 5 5
Hemorrhage/Bleeding 5 5
Keratitis 5 5
Blurred Vision 4 4
Retinal Injury 3 3
Cataract 3 3
Eye Pain 3 3
Vitreous Hemorrhage 3 3
Loss of Vision 2 2
Flashers 2 2
Pain 2 2
Perforation 1 1
Red Eye(s) 1 1
Nerve Damage 1 1
Tissue Damage 1 1
Cardiac Arrest 1 1
Vitreous Floaters 1 1
Glaucoma 1 1
Corneal Edema 1 1
Dry Eye(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Intraocular Pressure Increased 1 1
Visual Disturbances 1 1
Burning Sensation 1 1
Heart Failure 1 1
Intraocular Pressure Decreased 1 1
Unspecified Eye / Vision Problem 1 1
Swelling/ Edema 1 1
Partial thickness (Second Degree) Burn 1 1
Radiation Exposure, Unintended 1 1
No Information 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
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