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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 3
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

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 114 114
Adverse Event Without Identified Device or Use Problem 63 63
Power Problem 41 41
Appropriate Term/Code Not Available 25 25
Output below Specifications 14 14
Failure to Fire 13 13
Unexpected Shutdown 12 12
Unexpected Therapeutic Results 11 11
Failure to Deliver Energy 10 10
Electrical /Electronic Property Problem 10 10
Output Problem 10 10
Therapeutic or Diagnostic Output Failure 10 10
Firing Problem 8 8
Loss of Power 7 7
Device Operates Differently Than Expected 6 6
Use of Device Problem 6 6
Intermittent Energy Output 6 6
Insufficient Information 5 5
Break 5 5
Device Operational Issue 5 5
Defective Component 5 5
No Display/Image 4 4
Misfocusing 4 4
Failure to Align 4 4
Inappropriate or Unexpected Reset 4 4
Self-Activation or Keying 4 4
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Display or Visual Feedback Problem 3 3
Material Separation 3 3
Patient-Device Incompatibility 3 3
Failure to Power Up 2 2
Intermittent Loss of Power 2 2
Improper Device Output 2 2
Device Inoperable 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 2 2
Device Displays Incorrect Message 2 2
Intermittent Continuity 1 1
Connection Problem 1 1
No Audible Prompt/Feedback 1 1
Misfire 1 1
Increase in Pressure 1 1
Complete Loss of Power 1 1
Positioning Problem 1 1
Retraction Problem 1 1
Smoking 1 1
Crack 1 1
Calibration Problem 1 1
Failure to Shut Off 1 1
Inadequate User Interface 1 1
No Apparent Adverse Event 1 1
Physical Property Issue 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Fitting Problem 1 1
Power Conditioning Problem 1 1
Product Quality Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Reset Problem 1 1
Device Fell 1 1
Incomplete or Inadequate Connection 1 1
Energy Output To Patient Tissue Incorrect 1 1
Installation-Related Problem 1 1
Protective Measures Problem 1 1
Device Emits Odor 1 1
Communication or Transmission Problem 1 1
Component or Accessory Incompatibility 1 1
Inadequate or Insufficient Training 1 1
Expiration Date Error 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 144 144
No Known Impact Or Consequence To Patient 101 101
No Consequences Or Impact To Patient 42 42
Eye Burn 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Eye Injury 13 13
No Patient Involvement 13 13
Retinal Injury 11 11
Insufficient Information 10 10
Visual Impairment 7 7
No Code Available 6 6
Superficial (First Degree) Burn 6 6
Keratitis 5 5
No Information 5 5
Blurred Vision 3 3
Loss of Vision 3 3
Hemorrhage/Bleeding 3 3
Cataract 3 3
Flashers 3 3
Pain 3 3
Eye Pain 3 3
Radiation Exposure, Unintended 2 2
Vitreous Hemorrhage 2 2
Dry Eye(s) 2 2
Corneal Edema 1 1
Vitreous Floaters 1 1
Glaucoma 1 1
Hypersensitivity/Allergic reaction 1 1
Intraocular Pressure Increased 1 1
Red Eye(s) 1 1
Tissue Damage 1 1
Heart Failure 1 1
Inadequate Pain Relief 1 1
Electric Shock 1 1
Swelling/ Edema 1 1
Intraocular Pressure Decreased 1 1
Retinal Detachment 1 1
Burning Sensation 1 1
Injury 1 1
Nerve Damage 1 1
Cardiac Arrest 1 1
Corneal Scar 1 1
Perforation 1 1
Visual Disturbances 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Eye / Vision Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dutch Ophthalmic USA, Inc. II Jul-20-2021
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