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TPLC
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show TPLC since
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2023
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Device
laser, ophthalmic
Product Code
HQF
Regulation Number
886.4390
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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