Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
excimer laser system
Product Code
LZS
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
6
7
0
8
10
6
MDR Year
MDR Reports
MDR Events
2020
563
563
2021
263
263
2022
152
152
2023
128
128
2024
104
109
2025
146
147
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
842
846
Patient-Device Incompatibility
52
52
Energy Output Problem
45
45
Failure to Capture
31
31
Therapeutic or Diagnostic Output Failure
27
27
Insufficient Information
22
22
Appropriate Term/Code Not Available
20
20
Gas/Air Leak
19
19
Unexpected Therapeutic Results
18
18
Overcorrection
17
17
Misfire
14
14
Mechanical Problem
12
12
Output Problem
12
12
Undercorrection
11
11
Use of Device Problem
11
11
Improper or Incorrect Procedure or Method
11
11
Failure to Align
10
10
Computer Software Problem
7
7
Computer System Security Problem
7
7
Material Integrity Problem
6
6
Patient Device Interaction Problem
6
6
Material Opacification
6
6
Lack of Effect
6
6
Unintended System Motion
5
5
Device Displays Incorrect Message
4
4
Defective Device
4
4
Operating System Becomes Nonfunctional
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Inadequate Instructions for Non-Healthcare Professional
4
4
Leak/Splash
4
4
Poor Visibility
4
4
Incorrect Interpretation of Signal
4
4
Optical Problem
3
3
Fire
3
3
Product Quality Problem
3
3
Loss of Power
3
3
Electrical /Electronic Property Problem
3
3
Device Emits Odor
3
3
Capturing Problem
2
2
Filling Problem
2
2
Material Erosion
2
2
Device Sensing Problem
2
2
Failure to Sense
2
2
Self-Activation or Keying
2
2
Application Program Freezes, Becomes Nonfunctional
2
2
Unexpected Shutdown
2
2
Firing Problem
2
2
Noise, Audible
2
2
Unintended Movement
2
2
Positioning Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Visual Impairment
326
330
Blurred Vision
199
201
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
199
202
Keratitis
154
155
Dry Eye(s)
152
153
Visual Disturbances
115
115
Halo
88
88
Insufficient Information
84
84
Pain
75
75
No Clinical Signs, Symptoms or Conditions
75
75
Eye Pain
74
74
No Code Available
68
68
Corneal Clouding/Hazing
68
68
Uveitis
58
58
Vitreous Floaters
51
51
No Known Impact Or Consequence To Patient
47
47
Depression
43
43
Glaucoma
33
33
Inflammation
32
32
Headache
30
30
Suicidal Ideation
27
27
Loss of Vision
26
26
Red Eye(s)
26
26
Foreign Body Sensation in Eye
25
25
Unspecified Eye / Vision Problem
25
25
Anxiety
23
23
Discomfort
22
22
Burning Sensation
21
21
Increased Sensitivity
21
21
Increased Sensitivity
21
21
Corneal Abrasion
18
18
Emotional Changes
17
17
Eye Injury
16
16
Corneal Infiltrates
16
16
Therapeutic Response, Decreased
16
16
Corneal Scar
12
12
Neuralgia
12
12
Irritation
11
11
Cataract
10
10
Intraocular Pressure Increased
9
9
Therapeutic Effects, Unexpected
9
9
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
Itching Sensation
6
6
Impaired Healing
6
6
Corneal Edema
6
6
Unspecified Mental, Emotional or Behavioural Problem
6
6
Nerve Damage
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
AMO Manufacturing USA, LLC
II
Dec-29-2021
-
-