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TPLC
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show TPLC since
2009
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2019
2020
2021
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2024
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Device
excimer laser system
Product Code
LZS
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
2024
11
13
6
7
0
8
7
MDR Year
MDR Reports
MDR Events
2018
1601
1601
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
2346
2348
Insufficient Information
278
278
Patient-Device Incompatibility
115
115
Appropriate Term/Code Not Available
100
100
Improper or Incorrect Procedure or Method
89
89
Device Operates Differently Than Expected
76
76
Unexpected Therapeutic Results
75
75
Overcorrection
69
69
Device Displays Incorrect Message
67
67
Energy Output Problem
61
61
Therapeutic or Diagnostic Output Failure
49
49
Incorrect, Inadequate or Imprecise Result or Readings
38
38
Gas/Air Leak
34
34
Failure to Capture
31
31
Defective Device
27
27
Mechanical Problem
24
24
Output Problem
20
20
Computer Software Problem
19
19
Failure to Align
17
17
Device Sensing Problem
16
16
Use of Device Problem
15
15
Device Emits Odor
15
15
Electrical /Electronic Property Problem
11
11
Undercorrection
11
11
Material Integrity Problem
9
9
Misfire
8
8
Leak/Splash
7
7
Loose or Intermittent Connection
7
7
Computer System Security Problem
7
7
Device Inoperable
7
7
Material Opacification
7
7
Power Problem
7
7
Incorrect Measurement
7
7
Unintended Movement
7
7
Optical Problem
7
7
Output above Specifications
6
6
Defective Component
6
6
Lack of Effect
6
6
Calibration Problem
6
6
Material Erosion
6
6
Noise, Audible
6
6
Device Alarm System
5
5
Protective Measures Problem
5
5
Intermittent Continuity
5
5
Unintended System Motion
5
5
Self-Activation or Keying
5
5
Loss of Power
5
5
Poor Visibility
4
4
Failure to Calibrate
4
4
Inappropriate or Unexpected Reset
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Keratitis
816
816
Blurred Vision
768
770
Visual Impairment
612
615
No Code Available
409
409
Dry Eye(s)
327
328
No Known Impact Or Consequence To Patient
322
322
Pain
301
301
Halo
178
179
Increased Sensitivity
172
172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
161
161
Visual Disturbances
159
159
Foreign Body Sensation in Eye
138
138
Discomfort
136
136
Inflammation
103
103
Corneal Clouding/Hazing
97
97
Irritation
89
89
Corneal Abrasion
82
82
Erosion
76
76
Loss of Vision
70
70
Insufficient Information
67
67
Uveitis
67
67
Headache
66
66
Corneal Infiltrates
65
65
Vitreous Floaters
65
65
No Clinical Signs, Symptoms or Conditions
64
64
Eye Pain
62
62
Depression
61
61
Burning Sensation
61
61
Red Eye(s)
55
56
Therapeutic Effects, Unexpected
50
50
No Consequences Or Impact To Patient
48
48
Therapeutic Response, Decreased
40
40
Impaired Healing
38
38
Glaucoma
36
36
Eye Injury
35
35
Hypersensitivity/Allergic reaction
34
34
Anxiety
30
30
Swelling
28
28
Itching Sensation
27
28
Excessive Tear Production
27
27
Patient Problem/Medical Problem
26
26
Complaint, Ill-Defined
24
24
Corneal Ulcer
23
23
Emotional Changes
23
23
Suicidal Ideation
23
23
Unspecified Eye / Vision Problem
23
23
No Information
21
21
Corneal Edema
20
20
Unspecified Infection
18
18
Increased Sensitivity
18
18
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
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