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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
EYEQ INC.
  SUBSTANTIALLY EQUIVALENT 1
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 55 55

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 191 191
Adverse Event Without Identified Device or Use Problem 76 76
Appropriate Term/Code Not Available 43 43
Failure to Fire 38 38
Failure to Deliver Energy 27 27
Unexpected Shutdown 14 14
Use of Device Problem 12 12
Intermittent Energy Output 10 10
Power Problem 10 10
Unexpected Therapeutic Results 9 9
Therapeutic or Diagnostic Output Failure 9 9
Loss of Power 8 8
Insufficient Information 7 7
Electrical /Electronic Property Problem 6 6
Firing Problem 6 6
Break 4 4
No Display/Image 4 4
Improper or Incorrect Procedure or Method 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
Patient-Device Incompatibility 3 3
Defective Device 3 3
Contamination /Decontamination Problem 3 3
Noise, Audible 2 2
Device Handling Problem 2 2
Failure to Align 2 2
Failure to Power Up 1 1
Program or Algorithm Execution Problem 1 1
Component Missing 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Energy Spectrum Incorrect 1 1
Misfire 1 1
Key or Button Unresponsive/not Working 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Material Separation 1 1
Positioning Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Component Misassembled 1 1
Expiration Date Error 1 1
Smoking 1 1
Device Fell 1 1
Connection Problem 1 1
Complete Loss of Power 1 1
Application Program Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 243 243
Insufficient Information 85 85
Eye Burn 39 39
No Known Impact Or Consequence To Patient 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Eye Injury 15 15
Intraocular Pressure Increased 13 13
No Consequences Or Impact To Patient 13 13
Blurred Vision 9 9
Visual Impairment 9 9
Inflammation 8 8
Eye Pain 7 7
Superficial (First Degree) Burn 6 6
Loss of Vision 5 5
Hemorrhage/Bleeding 5 5
No Code Available 5 5
Corneal Edema 4 4
Keratitis 4 4
No Patient Involvement 4 4
Vitreous Hemorrhage 3 3
Unspecified Eye / Vision Problem 3 3
Intraocular Pressure Decreased 2 2
Vitreous Floaters 2 2
Pain 2 2
Burn(s) 2 2
Retinal Injury 2 2
Cataract 2 2
Iritis 2 2
Electric Shock 2 2
Corneal Clouding/Hazing 2 2
Visual Disturbances 1 1
Burning Sensation 1 1
Flashers 1 1
Cardiac Arrest 1 1
Nerve Damage 1 1
Perforation 1 1
Scar Tissue 1 1
Dry Eye(s) 1 1
Heart Failure 1 1
Eye Infections 1 1
Swelling/ Edema 1 1
Tissue Damage 1 1
Partial thickness (Second Degree) Burn 1 1
Red Eye(s) 1 1
Radiation Exposure, Unintended 1 1
Hypersensitivity/Allergic reaction 1 1
Unspecified Infection 1 1
Headache 1 1
Hyperemia 1 1
Uveitis 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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