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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
EYEQ INC.
SUBSTANTIALLY EQUIVALENT
1
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
55
55
Device Problems
MDRs with this Device Problem
Events in those MDRs
Energy Output Problem
191
191
Adverse Event Without Identified Device or Use Problem
76
76
Appropriate Term/Code Not Available
43
43
Failure to Fire
38
38
Failure to Deliver Energy
27
27
Unexpected Shutdown
14
14
Use of Device Problem
12
12
Intermittent Energy Output
10
10
Power Problem
10
10
Unexpected Therapeutic Results
9
9
Therapeutic or Diagnostic Output Failure
9
9
Loss of Power
8
8
Insufficient Information
7
7
Electrical /Electronic Property Problem
6
6
Firing Problem
6
6
Break
4
4
No Display/Image
4
4
Improper or Incorrect Procedure or Method
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
Patient-Device Incompatibility
3
3
Defective Device
3
3
Contamination /Decontamination Problem
3
3
Noise, Audible
2
2
Device Handling Problem
2
2
Failure to Align
2
2
Failure to Power Up
1
1
Program or Algorithm Execution Problem
1
1
Component Missing
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Energy Spectrum Incorrect
1
1
Misfire
1
1
Key or Button Unresponsive/not Working
1
1
Product Quality Problem
1
1
Retraction Problem
1
1
Material Separation
1
1
Positioning Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Component Misassembled
1
1
Expiration Date Error
1
1
Smoking
1
1
Device Fell
1
1
Connection Problem
1
1
Complete Loss of Power
1
1
Application Program Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
243
243
Insufficient Information
85
85
Eye Burn
39
39
No Known Impact Or Consequence To Patient
20
20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
19
19
Eye Injury
15
15
Intraocular Pressure Increased
13
13
No Consequences Or Impact To Patient
13
13
Blurred Vision
9
9
Visual Impairment
9
9
Inflammation
8
8
Eye Pain
7
7
Superficial (First Degree) Burn
6
6
Loss of Vision
5
5
Hemorrhage/Bleeding
5
5
No Code Available
5
5
Corneal Edema
4
4
Keratitis
4
4
No Patient Involvement
4
4
Vitreous Hemorrhage
3
3
Unspecified Eye / Vision Problem
3
3
Intraocular Pressure Decreased
2
2
Vitreous Floaters
2
2
Pain
2
2
Burn(s)
2
2
Retinal Injury
2
2
Cataract
2
2
Iritis
2
2
Electric Shock
2
2
Corneal Clouding/Hazing
2
2
Visual Disturbances
1
1
Burning Sensation
1
1
Flashers
1
1
Cardiac Arrest
1
1
Nerve Damage
1
1
Perforation
1
1
Scar Tissue
1
1
Dry Eye(s)
1
1
Heart Failure
1
1
Eye Infections
1
1
Swelling/ Edema
1
1
Tissue Damage
1
1
Partial thickness (Second Degree) Burn
1
1
Red Eye(s)
1
1
Radiation Exposure, Unintended
1
1
Hypersensitivity/Allergic reaction
1
1
Unspecified Infection
1
1
Headache
1
1
Hyperemia
1
1
Uveitis
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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