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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
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2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
lenses, soft contact, extended wear
Product Code
LPM
Regulation Number
886.5925
Device Class
3
Premarket Approvals (PMA)
2017
2018
2019
2020
2021
2022
2023
2024
79
59
55
45
28
40
15
23
MDR Year
MDR Reports
MDR Events
2017
215
215
2018
195
195
2019
189
189
2020
107
107
2021
103
103
2022
83
83
2023
118
118
2024
103
103
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
744
744
No Apparent Adverse Event
213
213
Insufficient Information
71
71
Patient-Device Incompatibility
22
22
Use of Device Problem
10
10
Defective Device
9
9
Improper or Incorrect Procedure or Method
8
8
Appropriate Term/Code Not Available
6
6
Material Split, Cut or Torn
4
4
Fitting Problem
4
4
Scratched Material
4
4
Microbial Contamination of Device
4
4
Difficult to Remove
4
4
Product Quality Problem
3
3
Device Operates Differently Than Expected
3
3
Break
2
2
Contamination /Decontamination Problem
2
2
Component Missing
2
2
Device Contamination with Chemical or Other Material
2
2
Torn Material
2
2
Defective Component
2
2
Inadequate Instructions for Non-Healthcare Professional
1
1
Material Opacification
1
1
Entrapment of Device
1
1
Contamination
1
1
Patient Device Interaction Problem
1
1
Degraded
1
1
Material Discolored
1
1
Unexpected Color
1
1
Device Handling Problem
1
1
Sticking
1
1
Inadequacy of Device Shape and/or Size
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Unfold or Unwrap
1
1
Material Separation
1
1
Material Integrity Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
488
488
Red Eye(s)
455
455
Pain
263
263
Keratitis
234
234
Bacterial Infection
198
198
Irritation
164
164
Discomfort
161
161
Eye Pain
153
153
Conjunctivitis
149
149
Foreign Body Sensation in Eye
146
146
Blurred Vision
129
129
Excessive Tear Production
128
128
Corneal Scar
120
120
Eye Infections
99
99
Unspecified Infection
93
93
Swelling
92
92
Itching Sensation
89
89
Dry Eye(s)
87
87
Burning Sensation
85
85
Corneal Infiltrates
84
84
Discharge
77
77
Corneal Abrasion
70
70
Inflammation
63
63
Eye Injury
54
54
Visual Disturbances
46
46
Loss of Vision
42
42
Acanthameba Keratitis
39
39
Visual Impairment
39
39
Local Reaction
38
38
Corneal Edema
36
36
Fungal Infection
20
20
Swelling/ Edema
19
19
Iritis
19
19
Neovascularization
17
17
Intraocular Infection
15
15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Headache
13
13
Hypopyon
13
13
Erosion
11
11
No Code Available
11
11
Abscess
10
10
Hypersensitivity/Allergic reaction
10
10
Corneal Clouding/Hazing
10
10
Erythema
9
9
Hyperemia
8
8
Fluid Discharge
8
8
Uveitis
8
8
Ulcer
7
7
Unspecified Eye / Vision Problem
7
7
Skin Inflammation/ Irritation
6
6
Recalls
Manufacturer
Recall Class
Date Posted
1
Allied Vision Group Inc
II
Apr-29-2020
2
CooperVision Inc.
II
Jan-27-2020
3
CooperVision Inc.
III
Feb-23-2018
4
CooperVision, Inc.
II
Mar-01-2023
5
Johnson & Johnson Vision Care, Inc.
II
Mar-27-2018
6
Lens.com
II
Dec-05-2019
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