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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
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
ELLEX MEDICAL PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
EMTRON ELEKTRONIK VE MEKANIK SANAYI VE TICARET LIM
  SUBSTANTIALLY EQUIVALENT 1
IRIDEX CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
LIGHT-MED(USA), INC.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
LIGHTMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS BE, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC VISION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIDIAN AG
  SUBSTANTIALLY EQUIVALENT 2
NIDEK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
NORLASE
  SUBSTANTIALLY EQUIVALENT 1
NORLASE APS
  SUBSTANTIALLY EQUIVALENT 2
OPHTHALMED LLC
  SUBSTANTIALLY EQUIVALENT 1
QUANTEL MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TOPCON MEDICAL LASER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 80 80
2016 108 108
2017 77 77
2018 82 82
2019 66 66
2020 72 72
2021 100 100
2022 111 111
2023 92 92
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Energy Output Problem 178 178
Adverse Event Without Identified Device or Use Problem 85 85
Device Operates Differently Than Expected 76 76
Power Problem 69 69
Output below Specifications 47 47
Appropriate Term/Code Not Available 47 47
Output Problem 26 26
Failure to Fire 25 25
Failure to Deliver Energy 23 23
Unexpected Therapeutic Results 22 22
Loss of Power 18 18
Insufficient Information 15 15
Unexpected Shutdown 15 15
Electrical /Electronic Property Problem 13 13
Misfocusing 13 13
Device Displays Incorrect Message 12 12
Device Inoperable 12 12
Device Operational Issue 12 12
Nonstandard Device 11 11
Self-Activation or Keying 11 11
Therapeutic or Diagnostic Output Failure 11 11
Intermittent Energy Output 10 10
Use of Device Problem 9 9
Firing Problem 8 8
Break 7 7
Defective Component 6 6
No Display/Image 5 5
Inappropriate or Unexpected Reset 5 5
Improper Device Output 4 4
Display or Visual Feedback Problem 4 4
Device Alarm System 4 4
Material Separation 4 4
Failure to Align 4 4
Defective Device 4 4
Patient-Device Incompatibility 3 3
Contamination /Decontamination Problem 3 3
Component or Accessory Incompatibility 3 3
Improper or Incorrect Procedure or Method 3 3
Failure to Power Up 3 3
Device Emits Odor 3 3
Protective Measures Problem 3 3
Noise, Audible 3 3
Device Handling Problem 2 2
Inadequate User Interface 2 2
Intermittent Loss of Power 2 2
Mechanical Jam 2 2
Energy Output To Patient Tissue Incorrect 2 2
Material Discolored 2 2
Mechanical Problem 2 2
Power Conditioning Problem 2 2
Component Missing 2 2
Fitting Problem 2 2
Calibration Problem 2 2
Connection Problem 2 2
Failure to Shut Off 2 2
Device Contamination with Chemical or Other Material 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Electronic Property Issue 1 1
Environmental Particulates 1 1
Application Program Problem 1 1
Computer Operating System Problem 1 1
Communication or Transmission Problem 1 1
No Audible Prompt/Feedback 1 1
Inaccurate Delivery 1 1
Suction Problem 1 1
Expiration Date Error 1 1
Misfire 1 1
Split 1 1
Sparking 1 1
Malposition of Device 1 1
Inadequate or Insufficient Training 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Increase in Pressure 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Output above Specifications 1 1
Overheating of Device 1 1
Peeled/Delaminated 1 1
Thermal Decomposition of Device 1 1
Computer Software Problem 1 1
Intermittent Continuity 1 1
Use of Incorrect Control/Treatment Settings 1 1
Crack 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Image Display Error/Artifact 1 1
Inadequate Instructions for Healthcare Professional 1 1
Poor Quality Image 1 1
Mechanics Altered 1 1
No Fail-Safe Mechanism 1 1
Inadequate Lighting 1 1
Installation-Related Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Reset Problem 1 1
Operating System Becomes Nonfunctional 1 1
Optical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 225 225
No Known Impact Or Consequence To Patient 213 213
No Consequences Or Impact To Patient 105 105
No Patient Involvement 41 41
Eye Burn 40 40
No Information 23 23
Eye Injury 20 20
Insufficient Information 19 19
Retinal Injury 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Visual Impairment 14 14
No Code Available 12 12
Keratitis 9 9
Hemorrhage/Bleeding 7 7
Pain 6 6
Blurred Vision 6 6
Superficial (First Degree) Burn 6 6
Therapeutic Effects, Unexpected 5 5
Visual Disturbances 5 5
Vitreous Hemorrhage 4 4
Loss of Vision 4 4
Dry Eye(s) 4 4
Flashers 4 4
Glaucoma 3 3
Cataract 3 3
Eye Pain 3 3
Injury 2 2
Inadequate Pain Relief 2 2
Radiation Exposure, Unintended 2 2
Burn(s) 2 2
Vitreous Floaters 2 2
Red Eye(s) 2 2
Halo 2 2
Discomfort 1 1
Heart Failure 1 1
Burning Sensation 1 1
Retinal Detachment 1 1
Tissue Damage 1 1
Vertigo 1 1
Headache 1 1
Cardiac Arrest 1 1
Corneal Edema 1 1
Corneal Scar 1 1
Perforation 1 1
Laceration(s) 1 1
Nerve Damage 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Intraocular Pressure Increased 1 1
Vitreous Detachment 1 1
Depression 1 1
Burn, Thermal 1 1
Electric Shock 1 1
Intraocular Pressure Decreased 1 1
Unspecified Eye / Vision Problem 1 1
Swelling/ Edema 1 1
Partial thickness (Second Degree) Burn 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
3 Laserex Systems Inc. II Apr-07-2016
4 Nidek Inc II Feb-19-2015
5 Topcon Medical Laser Systems, Inc II Aug-11-2016
6 Ziemer Usa Inc II Jan-15-2015
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