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TPLC
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show TPLC since
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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
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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