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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 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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