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TPLC
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Device
laser, ophthalmic
Regulation Description
Ophthalmic laser.
Product Code
HQF
Regulation Number
886.4390
Device Class
2
Premarket Reviews
Manufacturer
Decision
BEAVER-VISITEC INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
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
IRIDEX CORPORATION
SUBSTANTIALLY EQUIVALENT
4
LUMENIS BE, INC.
SUBSTANTIALLY EQUIVALENT
1
LUTRONIC VISION, INC.
SUBSTANTIALLY EQUIVALENT
1
MERIDIAN AG
SUBSTANTIALLY EQUIVALENT
2
NIDEK CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NORLASE
SUBSTANTIALLY EQUIVALENT
1
NORLASE APS
SUBSTANTIALLY EQUIVALENT
2
QUANTEL MEDICAL
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
72
72
2021
100
100
2022
111
111
2023
92
92
2024
75
75
2025
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Energy Output Problem
187
187
Adverse Event Without Identified Device or Use Problem
72
72
Appropriate Term/Code Not Available
43
43
Failure to Deliver Energy
27
27
Failure to Fire
25
25
Unexpected Shutdown
14
14
Intermittent Energy Output
10
10
Power Problem
10
10
Use of Device Problem
10
10
Therapeutic or Diagnostic Output Failure
9
9
Loss of Power
8
8
Unexpected Therapeutic Results
8
8
Insufficient Information
7
7
Electrical /Electronic Property Problem
6
6
Firing Problem
6
6
Break
4
4
No Display/Image
4
4
Device Operational Issue
4
4
Output Problem
4
4
Defective Component
4
4
Output below Specifications
3
3
Misfocusing
3
3
Display or Visual Feedback Problem
3
3
Self-Activation or Keying
3
3
Contamination /Decontamination Problem
3
3
Patient-Device Incompatibility
3
3
Failure to Align
2
2
Defective Device
2
2
Device Handling Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Noise, Audible
2
2
Key or Button Unresponsive/not Working
1
1
Misfire
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Program or Algorithm Execution Problem
1
1
Positioning Problem
1
1
Component Missing
1
1
Energy Spectrum Incorrect
1
1
Product Quality Problem
1
1
Retraction Problem
1
1
Material Separation
1
1
Expiration Date Error
1
1
Device Contamination with Chemical or Other Material
1
1
Component Misassembled
1
1
Smoking
1
1
Device Fell
1
1
Connection Problem
1
1
Complete Loss of Power
1
1
Image Display Error/Artifact
1
1
Inappropriate or Unexpected Reset
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
238
238
Insufficient Information
70
70
Eye Burn
39
39
No Known Impact Or Consequence To Patient
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Eye Injury
14
14
No Consequences Or Impact To Patient
13
13
Intraocular Pressure Increased
10
10
Blurred Vision
8
8
Visual Impairment
8
8
Inflammation
7
7
Superficial (First Degree) Burn
6
6
Eye Pain
6
6
No Code Available
5
5
Loss of Vision
5
5
Hemorrhage/Bleeding
5
5
Keratitis
4
4
No Patient Involvement
4
4
Corneal Edema
4
4
Unspecified Eye / Vision Problem
3
3
Vitreous Hemorrhage
3
3
Corneal Clouding/Hazing
2
2
Iritis
2
2
Electric Shock
2
2
Cataract
2
2
Intraocular Pressure Decreased
2
2
Retinal Injury
2
2
Burn(s)
2
2
Pain
2
2
Vitreous Floaters
2
2
Uveitis
1
1
Hyperemia
1
1
Headache
1
1
Partial thickness (Second Degree) Burn
1
1
Tissue Damage
1
1
Swelling/ Edema
1
1
Eye Infections
1
1
Scar Tissue
1
1
Nerve Damage
1
1
Burning Sensation
1
1
Flashers
1
1
Cardiac Arrest
1
1
Heart Failure
1
1
Perforation
1
1
Dry Eye(s)
1
1
Radiation Exposure, Unintended
1
1
Red Eye(s)
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Infection
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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