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TPLC
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Device
excimer laser system
Product Code
LZS
Device Class
3
Premarket Approvals (PMA)
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
14
4
10
11
13
6
7
0
8
5
MDR Year
MDR Reports
MDR Events
2015
1146
1146
2016
808
808
2017
1359
1359
2018
1601
1601
2019
1060
1060
2020
563
563
2021
263
263
2022
152
152
2023
128
128
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3636
3636
Insufficient Information
1229
1229
Device Operates Differently Than Expected
393
393
Device Displays Incorrect Message
212
212
Appropriate Term/Code Not Available
177
177
Improper or Incorrect Procedure or Method
173
173
Patient-Device Incompatibility
162
162
Overcorrection
137
137
Unexpected Therapeutic Results
133
133
Energy Output Problem
83
83
Therapeutic or Diagnostic Output Failure
75
75
Device Inoperable
49
49
Gas/Air Leak
45
45
Incorrect, Inadequate or Imprecise Result or Readings
39
39
Use of Device Problem
34
34
Output Problem
31
31
Unintended Movement
30
30
Defective Device
29
29
Mechanical Problem
27
27
Device Emits Odor
25
25
Failure to Capture
24
24
Failure to Align
24
24
Computer Software Problem
23
23
Use of Incorrect Control/Treatment Settings
22
22
Device Sensing Problem
20
20
Electrical /Electronic Property Problem
17
17
Output below Specifications
16
16
Output above Specifications
12
12
Loose or Intermittent Connection
12
12
Calibration Problem
11
11
Failure to Fire
11
11
Undercorrection
11
11
Unstable
10
10
Suction Problem
10
10
Leak/Splash
10
10
Loss of Power
10
10
Defective Component
9
9
Material Integrity Problem
9
9
Noise, Audible
9
9
Power Problem
9
9
Improper Device Output
8
8
Device Stops Intermittently
8
8
Incorrect Measurement
8
8
Material Opacification
8
8
Device Alarm System
8
8
Material Erosion
7
7
Unintended System Motion
7
7
Malposition of Device
7
7
Misfire
7
7
Computer System Security Problem
7
7
Positioning Problem
7
7
Optical Problem
7
7
Lack of Effect
6
6
Failure to Power Up
6
6
Self-Activation or Keying
6
6
Smoking
6
6
Application Interface Becomes Non-Functional Or Program Exits Abnormally
6
6
Signal Artifact/Noise
5
5
Air Leak
5
5
Intermittent Continuity
5
5
Failure to Deliver Energy
5
5
Inadequate Instructions for Non-Healthcare Professional
5
5
Operating System Becomes Nonfunctional
5
5
Visual Prompts will not Clear
5
5
Programming Issue
5
5
Protective Measures Problem
5
5
Data Problem
4
4
Computer Operating System Problem
4
4
Patient Device Interaction Problem
4
4
Firing Problem
4
4
Vibration
4
4
Failure to Calibrate
4
4
Fumes or Vapors
4
4
Inappropriate or Unexpected Reset
4
4
Power Conditioning Problem
4
4
Failure to Sense
4
4
Device Slipped
4
4
Display or Visual Feedback Problem
4
4
Energy Output To Patient Tissue Incorrect
4
4
Fire
4
4
False Reading From Device Non-Compliance
3
3
Break
3
3
Defective Alarm
3
3
Device Reprocessing Problem
3
3
Detachment Of Device Component
3
3
Component Falling
3
3
Inadequacy of Device Shape and/or Size
3
3
Product Quality Problem
3
3
No Device Output
3
3
Misfocusing
3
3
Human Factors Issue
3
3
Human-Device Interface Problem
3
3
Application Program Problem
3
3
Low Readings
3
3
Incorrect Or Inadequate Test Results
3
3
Microbial Contamination of Device
3
3
Torn Material
3
3
Device Handling Problem
3
3
Unexpected Shutdown
3
3
Mechanics Altered
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
1421
1421
Keratitis
1391
1391
Visual Impairment
1000
1001
No Code Available
948
948
Dry Eye(s)
751
751
No Known Impact Or Consequence To Patient
615
615
Pain
512
512
Increased Sensitivity
355
355
Visual Disturbances
275
275
Halo
262
263
Inflammation
245
245
Corneal Clouding/Hazing
245
245
Discomfort
229
229
Foreign Body Sensation in Eye
212
212
Irritation
190
190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
142
142
Loss of Vision
139
139
No Consequences Or Impact To Patient
138
138
Erosion
136
136
Headache
128
128
Complaint, Ill-Defined
128
128
Corneal Abrasion
122
122
Burning Sensation
111
111
Therapeutic Effects, Unexpected
109
109
Red Eye(s)
98
99
Corneal Infiltrates
96
96
Hypersensitivity/Allergic reaction
89
89
Vitreous Floaters
85
85
Eye Injury
85
85
Uveitis
80
80
Depression
80
80
No Information
66
66
Therapeutic Response, Decreased
64
64
Insufficient Information
61
61
No Clinical Signs, Symptoms or Conditions
58
58
Eye Pain
57
57
Excessive Tear Production
54
54
Impaired Healing
54
54
Itching Sensation
53
54
Swelling
47
47
Anxiety
46
46
Unspecified Infection
45
45
Patient Problem/Medical Problem
39
39
Glaucoma
37
37
Corneal Ulcer
36
36
Reaction
32
32
Edema
29
29
Corneal Edema
29
29
Emotional Changes
27
27
Erythema
26
26
Intraocular Pressure Increased
23
23
Cataract
22
22
Unspecified Eye / Vision Problem
22
22
Suicidal Ideation
20
20
Corneal Scar
20
20
Phototoxicity
19
19
Retinal Detachment
17
17
Increased Sensitivity
17
17
Scarring
16
16
Nausea
16
16
Abrasion
14
14
Injury
14
14
Iritis
13
13
Disability
12
12
Vitreous Detachment
12
12
Dizziness
12
12
Discharge
12
12
Bacterial Infection
11
12
Conjunctivitis
11
11
Neuralgia
11
11
Foreign Body In Patient
11
11
No Patient Involvement
10
10
Acanthameba Keratitis
10
10
Postoperative refraction, unexpected
9
9
Nerve Damage
8
8
Fatigue
8
8
Death
8
8
Cataract, Induced
8
8
Tissue Damage
8
8
Sleep Dysfunction
8
8
Inadequate Pain Relief
7
7
Retinal Tear
7
7
Infiltration into Tissue
7
7
Tissue Breakdown
7
7
Toxic Anterior Segment Syndrome (TASS)
7
7
UGH (Uveitis Glaucoma Hyphema) Syndrome
7
7
Ulcer
6
6
Clouding, Central Corneal
6
6
Other (for use when an appropriate patient code cannot be identified)
6
6
Microcysts, Epithelial
6
6
Viral Infection
5
5
Optical Nerve Damage
5
5
Vomiting
5
5
Staphylococcus Aureus
5
5
Decreased Sensitivity
5
5
Fibrosis
4
4
Scar Tissue
4
4
Seizures
4
4
Neuropathy
4
4
Laceration(s)
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
2
Nidek Inc
II
Mar-20-2017
3
Nidek Inc
II
Jun-04-2015
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