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TPLC
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show TPLC since
2009
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2011
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2014
2015
2016
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2019
2020
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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)
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
26
35
43
79
59
55
45
28
40
15
22
MDR Year
MDR Reports
MDR Events
2014
110
110
2015
143
143
2016
220
220
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
876
876
No Apparent Adverse Event
406
406
Insufficient Information
144
144
Patient-Device Incompatibility
29
29
Improper or Incorrect Procedure or Method
21
21
Device Operates Differently Than Expected
17
17
Appropriate Term/Code Not Available
13
13
Torn Material
13
13
Use of Device Problem
12
12
Defective Device
11
11
Difficult to Remove
7
7
Scratched Material
6
6
Fitting Problem
6
6
Microbial Contamination of Device
5
5
Contamination
4
4
Material Split, Cut or Torn
4
4
Device Contamination with Chemical or Other Material
4
4
Material Integrity Problem
3
3
Product Quality Problem
3
3
Break
3
3
Inadequacy of Device Shape and/or Size
2
2
Sticking
2
2
Split
2
2
Therapeutic or Diagnostic Output Failure
2
2
Defective Component
2
2
Device Handling Problem
2
2
Contamination /Decontamination Problem
2
2
Component Missing
2
2
Failure to Unfold or Unwrap
1
1
Missing Value Reason
1
1
Material Separation
1
1
Tear, Rip or Hole in Device Packaging
1
1
Labelling, Instructions for Use or Training Problem
1
1
Out-Of-Box Failure
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Degraded
1
1
Device Markings/Labelling Problem
1
1
Peeled/Delaminated
1
1
Shelf Life Exceeded
1
1
Fogging
1
1
Device Unsafe to Use in Environment
1
1
Unexpected Color
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Expiration Issue
1
1
Positioning Problem
1
1
Patient Device Interaction Problem
1
1
Material Discolored
1
1
Device Packaging Compromised
1
1
Entrapment of Device
1
1
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Corneal Ulcer
688
688
Red Eye(s)
617
617
Pain
427
427
Keratitis
313
313
Bacterial Infection
262
262
Discomfort
255
255
Irritation
248
248
Conjunctivitis
199
199
Unspecified Infection
199
199
Excessive Tear Production
178
178
Blurred Vision
175
175
Foreign Body Sensation in Eye
168
168
Eye Pain
153
153
Corneal Scar
143
143
Swelling
143
143
Itching Sensation
128
128
Discharge
126
126
Corneal Abrasion
118
118
Dry Eye(s)
118
118
Burning Sensation
118
118
Corneal Infiltrates
115
115
Eye Infections
99
99
Inflammation
86
86
Loss of Vision
83
83
Eye Injury
68
68
Visual Impairment
55
55
Visual Disturbances
51
51
Corneal Edema
49
49
Acanthameba Keratitis
41
41
Iritis
39
39
Local Reaction
38
38
Fungal Infection
26
26
Neovascularization
25
25
Intraocular Infection
23
23
No Code Available
20
20
Hypopyon
19
19
Swelling/ Edema
19
19
Headache
17
17
Corneal Clouding/Hazing
17
17
Scar Tissue
16
16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
15
15
Abscess
15
15
Hyperemia
14
14
Erosion
14
14
Erythema
13
13
Ulcer
12
12
Uveitis
12
12
Fluid Discharge
12
12
Hypersensitivity/Allergic reaction
11
11
Complaint, Ill-Defined
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
Allied Vision Group Inc
II
Apr-29-2020
2
Cooper Vision Caribbean Corp.
II
Dec-15-2014
3
CooperVision Inc.
II
Jan-27-2020
4
CooperVision Inc.
III
Feb-23-2018
5
CooperVision, Inc.
II
Mar-01-2023
6
Intertrade Imports Inc.
II
Jan-12-2015
7
Johnson & Johnson Vision Care, Inc.
II
Mar-27-2018
8
Lens.com
II
Dec-05-2019
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