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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laser, ophthalmic
Product CodeHQF
Regulation Number 886.4390
Device Class 2


Premarket Reviews
ManufacturerDecision
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 1
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
NORLASE
  SUBSTANTIALLY EQUIVALENT 1
NORLASE APS
  SUBSTANTIALLY EQUIVALENT 2
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TOPCON MEDICAL LASER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 82 82
2019 66 66
2020 72 72
2021 100 100
2022 111 111
2023 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 152 152
Adverse Event Without Identified Device or Use Problem 64 64
Appropriate Term/Code Not Available 44 44
Power Problem 41 41
Unexpected Shutdown 15 15
Failure to Deliver Energy 15 15
Failure to Fire 14 14
Output below Specifications 14 14
Output Problem 11 11
Unexpected Therapeutic Results 11 11
Electrical /Electronic Property Problem 10 10
Intermittent Energy Output 10 10
Therapeutic or Diagnostic Output Failure 10 10
Firing Problem 8 8
Loss of Power 8 8
Break 6 6
Defective Component 6 6
Self-Activation or Keying 6 6
Use of Device Problem 6 6
Device Operates Differently Than Expected 6 6
Device Operational Issue 5 5
Insufficient Information 5 5
Inappropriate or Unexpected Reset 4 4
Failure to Align 4 4
No Display/Image 4 4
Misfocusing 4 4
Display or Visual Feedback Problem 3 3
Defective Device 3 3
Material Separation 3 3
Patient-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Noise, Audible 3 3
Device Inoperable 2 2
Connection Problem 2 2
Improper Device Output 2 2
Improper or Incorrect Procedure or Method 2 2
Device Displays Incorrect Message 2 2
Component Missing 2 2
Failure to Power Up 2 2
Intermittent Loss of Power 2 2
Increase in Pressure 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 Output To Patient Tissue Incorrect 1 1
Image Display Error/Artifact 1 1
Inadequate or Insufficient Training 1 1
Expiration Date Error 1 1
Misfire 1 1
Fitting Problem 1 1
No Audible Prompt/Feedback 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Failure to Shut Off 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Calibration Problem 1 1
No Apparent Adverse Event 1 1
Protective Measures Problem 1 1
Reset Problem 1 1
Operating System Becomes Nonfunctional 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Complete Loss of Power 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 207 207
No Known Impact Or Consequence To Patient 101 101
No Consequences Or Impact To Patient 42 42
Eye Burn 37 37
Eye Injury 15 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
No Patient Involvement 13 13
Retinal Injury 11 11
Insufficient Information 11 11
Visual Impairment 7 7
Superficial (First Degree) Burn 6 6
No Code Available 6 6
No Information 5 5
Keratitis 5 5
Hemorrhage/Bleeding 3 3
Pain 3 3
Flashers 3 3
Cataract 3 3
Loss of Vision 3 3
Blurred Vision 3 3
Eye Pain 3 3
Radiation Exposure, Unintended 2 2
Vitreous Hemorrhage 2 2
Dry Eye(s) 2 2
Cardiac Arrest 1 1
Corneal Edema 1 1
Corneal Scar 1 1
Vitreous Floaters 1 1
Glaucoma 1 1
Perforation 1 1
Red Eye(s) 1 1
Retinal Detachment 1 1
Hypersensitivity/Allergic reaction 1 1
Intraocular Pressure Increased 1 1
Nerve Damage 1 1
Burning Sensation 1 1
Electric Shock 1 1
Partial thickness (Second Degree) Burn 1 1
Visual Disturbances 1 1
Tissue Damage 1 1
Heart Failure 1 1
Injury 1 1
Inadequate Pain Relief 1 1
Intraocular Pressure Decreased 1 1
Unspecified Eye / Vision Problem 1 1
Swelling/ Edema 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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