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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 AG
  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
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 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 120 120
Adverse Event Without Identified Device or Use Problem 63 63
Power Problem 41 41
Appropriate Term/Code Not Available 28 28
Output below Specifications 14 14
Failure to Fire 14 14
Unexpected Shutdown 13 13
Output Problem 11 11
Unexpected Therapeutic Results 11 11
Electrical /Electronic Property Problem 10 10
Failure to Deliver Energy 10 10
Therapeutic or Diagnostic Output Failure 10 10
Firing Problem 8 8
Loss of Power 8 8
Use of Device Problem 6 6
Intermittent Energy Output 6 6
Device Operates Differently Than Expected 6 6
Device Operational Issue 5 5
Insufficient Information 5 5
Defective Component 5 5
Self-Activation or Keying 5 5
Break 5 5
No Display/Image 4 4
Misfocusing 4 4
Failure to Align 4 4
Inappropriate or Unexpected Reset 4 4
Contamination /Decontamination Problem 3 3
Patient-Device Incompatibility 3 3
Defective Device 3 3
Display or Visual Feedback Problem 3 3
Material Separation 3 3
Failure to Power Up 2 2
Device Displays Incorrect Message 2 2
Component Missing 2 2
Improper or Incorrect Procedure or Method 2 2
Improper Device Output 2 2
Device Inoperable 2 2
Intermittent Loss of Power 2 2
Incomplete or Inadequate Connection 1 1
No Apparent Adverse Event 1 1
Device Fell 1 1
Complete Loss of Power 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Inadequate User Interface 1 1
Failure to Shut Off 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Connection Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Reset Problem 1 1
Physical Property Issue 1 1
Positioning Problem 1 1
Fitting Problem 1 1
No Audible Prompt/Feedback 1 1
Inadequate or Insufficient Training 1 1
Power Conditioning Problem 1 1
Expiration Date Error 1 1
Misfire 1 1
Calibration Problem 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Intermittent Continuity 1 1
Crack 1 1
Device Emits Odor 1 1
Energy Output To Patient Tissue Incorrect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
No Known Impact Or Consequence To Patient 101 101
No Consequences Or Impact To Patient 42 42
Eye Burn 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
No Patient Involvement 13 13
Eye Injury 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
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