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TPLC
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show TPLC since
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2025
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Device
excimer laser system
Product Code
LZS
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
6
7
0
8
10
4
MDR Year
MDR Reports
MDR Events
2020
563
563
2021
263
263
2022
152
152
2023
128
128
2024
104
109
2025
14
15
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
756
760
Patient-Device Incompatibility
50
50
Energy Output Problem
44
44
Failure to Capture
31
31
Therapeutic or Diagnostic Output Failure
25
25
Insufficient Information
22
22
Appropriate Term/Code Not Available
20
20
Gas/Air Leak
18
18
Overcorrection
17
17
Mechanical Problem
12
12
Unexpected Therapeutic Results
11
11
Output Problem
11
11
Undercorrection
11
11
Improper or Incorrect Procedure or Method
10
10
Failure to Align
10
10
Use of Device Problem
9
9
Misfire
8
8
Computer System Security Problem
7
7
Computer Software Problem
7
7
Material Integrity Problem
6
6
Lack of Effect
6
6
Material Opacification
6
6
Unintended System Motion
5
5
Leak/Splash
4
4
Defective Device
4
4
Patient Device Interaction Problem
4
4
Poor Visibility
4
4
Operating System Becomes Nonfunctional
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Device Displays Incorrect Message
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Product Quality Problem
3
3
Electrical /Electronic Property Problem
3
3
Fire
3
3
Optical Problem
3
3
Incorrect Interpretation of Signal
3
3
Device Emits Odor
3
3
Loss of Power
3
3
Noise, Audible
2
2
Device Sensing Problem
2
2
Firing Problem
2
2
Failure to Sense
2
2
Filling Problem
2
2
Unintended Movement
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Capturing Problem
2
2
Material Erosion
2
2
Positioning Problem
2
2
Self-Activation or Keying
2
2
Problem with Sterilization
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Visual Impairment
306
310
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
174
177
Blurred Vision
158
160
Dry Eye(s)
133
134
Keratitis
123
124
Visual Disturbances
81
81
Insufficient Information
79
79
Halo
78
78
Pain
70
70
No Code Available
68
68
Eye Pain
66
66
No Clinical Signs, Symptoms or Conditions
65
65
Uveitis
58
58
Vitreous Floaters
48
48
No Known Impact Or Consequence To Patient
47
47
Depression
41
41
Corneal Clouding/Hazing
38
38
Glaucoma
33
33
Inflammation
32
32
Headache
27
27
Red Eye(s)
25
25
Foreign Body Sensation in Eye
25
25
Suicidal Ideation
24
24
Loss of Vision
24
24
Unspecified Eye / Vision Problem
24
24
Discomfort
22
22
Increased Sensitivity
21
21
Anxiety
21
21
Burning Sensation
20
20
Increased Sensitivity
18
18
Corneal Abrasion
18
18
Corneal Infiltrates
16
16
Therapeutic Response, Decreased
16
16
Eye Injury
16
16
Emotional Changes
15
15
Neuralgia
11
11
Irritation
11
11
Therapeutic Effects, Unexpected
9
9
Corneal Scar
9
9
Intraocular Pressure Increased
9
9
Cataract
8
8
Corneal Ulcer
8
8
UGH (Uveitis Glaucoma Hyphema) Syndrome
7
7
Toxic Anterior Segment Syndrome (TASS)
7
7
No Consequences Or Impact To Patient
7
7
Corneal Edema
6
6
Itching Sensation
6
6
Erosion
5
5
Nerve Damage
5
5
Impaired Healing
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
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