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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

MDR Year MDR Reports MDR Events
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 132 132
Insufficient Information 24 24
Defective Device 13 13
Improper or Incorrect Procedure or Method 12 12
Patient-Device Incompatibility 12 12
Material Split, Cut or Torn 7 7
Product Quality Problem 6 6
Break 4 4
Entrapment of Device 3 3
Material Fragmentation 2 2
Material Rupture 2 2
Use of Device Problem 2 2
Expiration Date Error 2 2
Torn Material 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
Packaging Problem 1 1
Device Or Device Fragments Location Unknown 1 1
Component Falling 1 1
Contamination 1 1
Fitting Problem 1 1
Component Missing 1 1
Material Separation 1 1
Sticking 1 1
Particulates 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 65 65
Pain 56 56
Red Eye(s) 52 52
Eye Injury 27 27
Keratitis 25 25
Eye Pain 25 25
Unspecified Infection 24 24
Blurred Vision 23 23
Eye Infections 22 22
Discomfort 22 22
Corneal Abrasion 21 21
Corneal Edema 19 19
Corneal Scar 18 18
Irritation 18 18
Visual Impairment 16 16
Loss of Vision 16 16
Corneal Infiltrates 16 16
Conjunctivitis 14 14
Excessive Tear Production 11 11
Acanthameba Keratitis 10 10
Inflammation 10 10
Discharge 9 9
Burning Sensation 9 9
Neovascularization 8 8
Foreign Body Sensation in Eye 8 8
Dry Eye(s) 7 7
Iritis 7 7
Ulcer 7 7
Headache 6 6
Bacterial Infection 6 6
Erosion 5 5
Swelling 5 5
Fungal Infection 5 5
Visual Disturbances 4 4
Itching Sensation 4 4
Purulent Discharge 3 3
Corneal Stromal Edema 3 3
No Code Available 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 2 2
Intraocular Pressure Decreased 2 2
Eye Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Vomiting 2 2
Halo 2 2
Reaction 2 2
Corneal Clouding/Hazing 2 2
Nausea 2 2
Hemorrhage/Bleeding 2 2
Hyphema 2 2
Hypopyon 2 2
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Staphylococcus Aureus 1 1
Laceration(s) 1 1
Erythema 1 1
Edema 1 1
Syncope 1 1
Abrasion 1 1
Abscess 1 1
Anoxia 1 1
Collapse 1 1
Coma 1 1
Loss of consciousness 1 1
Uveitis 1 1
Convulsion, Clonic 1 1
Injury 1 1
Meningitis 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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