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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device lens, contact, (disposable)
Product CodeMVN
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
YUNG SHENG OPTICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 20 20
2015 10 10
2016 18 18
2017 23 23
2018 32 32
2019 34 34
2020 32 32
2021 24 24
2022 18 18
2023 24 24
2024 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 153 153
Insufficient Information 27 27
Improper or Incorrect Procedure or Method 14 14
Defective Device 13 13
Patient-Device Incompatibility 12 12
Material Split, Cut or Torn 7 7
Product Quality Problem 6 6
Break 4 4
Torn Material 4 4
Entrapment of Device 3 3
Material Fragmentation 2 2
Use of Device Problem 2 2
Expiration Date Error 2 2
Material Rupture 2 2
Device Contamination with Chemical or Other Material 2 2
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Appropriate Term/Code Not Available 1 1
Packaging Problem 1 1
Material Separation 1 1
Sticking 1 1
Fitting Problem 1 1
Component Missing 1 1
Device Or Device Fragments Location Unknown 1 1
Particulates 1 1
Off-Label Use 1 1
Component Falling 1 1
Contamination 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 87 87
Pain 66 66
Red Eye(s) 61 61
Unspecified Infection 28 28
Keratitis 28 28
Eye Injury 27 27
Eye Pain 25 25
Blurred Vision 24 24
Corneal Abrasion 24 24
Discomfort 23 23
Corneal Infiltrates 22 22
Eye Infections 22 22
Irritation 21 21
Corneal Scar 20 20
Corneal Edema 19 19
Loss of Vision 17 17
Visual Impairment 16 16
Discharge 15 15
Conjunctivitis 14 14
Acanthameba Keratitis 11 11
Excessive Tear Production 11 11
Burning Sensation 10 10
Inflammation 10 10
Foreign Body Sensation in Eye 10 10
Neovascularization 8 8
Bacterial Infection 8 8
Dry Eye(s) 7 7
Iritis 7 7
Ulcer 7 7
Scar Tissue 6 6
Headache 6 6
Erosion 5 5
Swelling 5 5
No Code Available 5 5
Fungal Infection 5 5
Visual Disturbances 4 4
Itching Sensation 4 4
Nausea 3 3
Corneal Stromal Edema 3 3
Purulent Discharge 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 2 2
Intraocular Pressure Decreased 2 2
Device Embedded In Tissue or Plaque 2 2
Eye Burn 2 2
Reaction 2 2
Vomiting 2 2
Halo 2 2
Therapeutic Response, Decreased 2 2
Abscess 2 2
Hemorrhage/Bleeding 2 2
Corneal Clouding/Hazing 2 2
Hyphema 2 2
Hypopyon 2 2
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Laceration(s) 1 1
Anaphylactic Shock 1 1
Anoxia 1 1
Syncope 1 1
Abrasion 1 1
Erythema 1 1
Edema 1 1
Injury 1 1
Meningitis 1 1
Convulsion, Clonic 1 1
Uveitis 1 1
Staphylococcus Aureus 1 1
Collapse 1 1
Coma 1 1
Loss of consciousness 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Unspecified Eye / Vision Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperVision Inc. III Apr-25-2018
2 Johnson & Johnson Vision Care, Inc. II Apr-17-2020
3 Johnson & Johnson Vision Care, Inc. II Mar-27-2018
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