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TPLC
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show TPLC since
2007
2008
2009
2010
2011
2012
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2014
2015
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2017
2018
2019
2020
2021
2022
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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
79
59
55
45
28
17
MDR Year
MDR Reports
MDR Events
2017
215
215
2018
195
195
2019
189
189
2020
107
107
2021
103
103
2022
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
525
525
No Apparent Adverse Event
209
209
Insufficient Information
49
49
Patient-Device Incompatibility
21
21
Defective Device
6
6
Improper or Incorrect Procedure or Method
5
5
Appropriate Term/Code Not Available
5
5
Use of Device Problem
3
3
Microbial Contamination of Device
3
3
Device Operates Differently Than Expected
3
3
Device Contamination with Chemical or Other Material
2
2
Defective Component
2
2
Difficult to Remove
2
2
Material Split, Cut or Torn
2
2
Contamination /Decontamination Problem
2
2
Torn Material
2
2
Scratched Material
1
1
Therapeutic or Diagnostic Output Failure
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Contamination
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Material Opacification
1
1
Product Quality Problem
1
1
Inadequate Instructions for Non-Healthcare Professional
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Integrity Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Red Eye(s)
367
367
Corneal Ulcer
356
356
Pain
261
261
Bacterial Infection
183
183
Keratitis
177
177
Irritation
164
164
Discomfort
153
153
Conjunctivitis
125
125
Excessive Tear Production
99
99
Foreign Body Sensation in Eye
94
94
Unspecified Infection
93
93
Swelling
92
92
Blurred Vision
83
83
Corneal Scar
81
81
Burning Sensation
77
77
Discharge
77
77
Itching Sensation
70
70
Dry Eye(s)
62
62
Inflammation
57
57
Corneal Infiltrates
57
57
Eye Pain
47
47
Corneal Abrasion
45
45
Eye Injury
35
35
Loss of Vision
34
34
Visual Impairment
31
31
Acanthameba Keratitis
28
28
Corneal Edema
24
24
Visual Disturbances
21
21
Iritis
18
18
Local Reaction
17
17
Intraocular Infection
15
15
Eye Infections
15
15
Neovascularization
14
14
Fungal Infection
12
12
No Code Available
11
11
Erosion
11
11
Abscess
10
10
Headache
10
10
Hypopyon
8
8
Erythema
7
7
Uveitis
6
6
Ulcer
6
6
Skin Inflammation/ Irritation
6
6
Increased Sensitivity
5
5
Corneal Clouding/Hazing
5
5
Hypersensitivity/Allergic reaction
4
4
Scarring
4
4
Swelling/ Edema
4
4
Fluid Discharge
4
4
Eye Burn
3
3
Caustic/Chemical Burns
3
3
Dizziness
3
3
Scar Tissue
3
3
Vitreous Floaters
3
3
Corneal Decompensation
3
3
Corneal Pannus
3
3
Edema
2
2
Purulent Discharge
2
2
Autoimmune Disorder
2
2
Cataract
2
2
Cellulitis
2
2
Foreign Body Reaction
2
2
Hypoxia
2
2
Nausea
2
2
Complaint, Ill-Defined
2
2
Injury
2
2
Deformity/ Disfigurement
2
2
Reaction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Abdominal Cramps
1
1
Foreign Body In Patient
1
1
No Known Impact Or Consequence To Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Ptosis
1
1
Tics/Tremor
1
1
Corneal Epithelial Microcysts
1
1
Insufficient Information
1
1
Reaction to Medicinal Component of Device
1
1
Regurgitation, Valvular
1
1
Overwear Syndrome
1
1
Vertigo
1
1
Misdiagnosis
1
1
Twitching
1
1
Necrosis Of Flap Tissue
1
1
Sjogren's Syndrome
1
1
Staphylococcus Aureus
1
1
High Blood Pressure/ Hypertension
1
1
Intraocular Pressure Increased
1
1
Fever
1
1
Hyperemia
1
1
Chemosis
1
1
Corneal Perforation
1
1
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
Johnson & Johnson Vision Care, Inc.
II
Mar-27-2018
5
Lens.com
II
Dec-05-2019
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