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TPLC
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show TPLC since
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2021
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2024
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Device
excimer laser system
Product Code
LZS
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
13
6
7
0
8
7
MDR Year
MDR Reports
MDR Events
2019
1060
1060
2020
563
563
2021
263
263
2022
152
152
2023
128
128
2024
70
72
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1498
1500
Patient-Device Incompatibility
76
76
Energy Output Problem
51
51
Therapeutic or Diagnostic Output Failure
48
48
Appropriate Term/Code Not Available
41
41
Insufficient Information
39
39
Improper or Incorrect Procedure or Method
36
36
Overcorrection
34
34
Failure to Capture
31
31
Unexpected Therapeutic Results
26
26
Incorrect, Inadequate or Imprecise Result or Readings
22
22
Device Displays Incorrect Message
22
22
Gas/Air Leak
21
21
Mechanical Problem
19
19
Defective Device
18
18
Output Problem
15
15
Failure to Align
12
12
Undercorrection
11
11
Use of Device Problem
11
11
Computer Software Problem
10
10
Misfire
8
8
Device Sensing Problem
8
8
Computer System Security Problem
7
7
Material Opacification
7
7
Device Emits Odor
7
7
Material Integrity Problem
6
6
Lack of Effect
6
6
Electrical /Electronic Property Problem
6
6
Unintended System Motion
5
5
Leak/Splash
5
5
Device Alarm System
5
5
Unintended Movement
5
5
Defective Component
5
5
Power Problem
4
4
Intermittent Continuity
4
4
Noise, Audible
4
4
Incorrect Measurement
4
4
Loss of Power
4
4
Material Erosion
4
4
Patient Device Interaction Problem
4
4
Operating System Becomes Nonfunctional
4
4
Optical Problem
4
4
Poor Visibility
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Product Quality Problem
3
3
Failure to Fire
3
3
Mechanics Altered
3
3
Fire
3
3
Self-Activation or Keying
3
3
Firing Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
419
421
Visual Impairment
415
417
Keratitis
410
410
Dry Eye(s)
190
191
Pain
189
189
No Code Available
182
182
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
161
161
No Known Impact Or Consequence To Patient
153
153
Visual Disturbances
128
128
Halo
122
122
Discomfort
84
84
Increased Sensitivity
74
74
Foreign Body Sensation in Eye
73
73
Insufficient Information
67
67
Corneal Clouding/Hazing
64
64
No Clinical Signs, Symptoms or Conditions
64
64
Eye Pain
62
62
Uveitis
61
61
Inflammation
59
59
Vitreous Floaters
57
57
Irritation
51
51
Depression
51
51
Corneal Abrasion
50
50
Loss of Vision
44
44
Corneal Infiltrates
42
42
Headache
41
41
Therapeutic Response, Decreased
37
37
Red Eye(s)
34
34
Glaucoma
33
33
Therapeutic Effects, Unexpected
32
32
No Consequences Or Impact To Patient
31
31
Burning Sensation
30
30
Anxiety
24
24
Suicidal Ideation
23
23
Unspecified Eye / Vision Problem
23
23
Erosion
23
23
Hypersensitivity/Allergic reaction
20
20
Eye Injury
19
19
Swelling
18
18
Increased Sensitivity
18
18
Emotional Changes
16
16
Impaired Healing
16
16
Corneal Ulcer
15
15
Corneal Scar
13
13
Itching Sensation
13
13
Cataract
12
12
Corneal Edema
11
11
Neuralgia
11
11
Excessive Tear Production
11
11
Edema
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
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