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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
2017 23 23
2018 32 32
2019 34 34
2020 32 32
2021 24 24
2022 18 18
2023 24 24
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 123 123
Insufficient Information 20 20
Improper or Incorrect Procedure or Method 11 11
Defective Device 11 11
Patient-Device Incompatibility 11 11
Material Split, Cut or Torn 8 8
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
Device Contamination with Chemical or Other Material 2 2
Torn Material 2 2
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1
Packaging Problem 1 1
Fitting Problem 1 1
Component Missing 1 1
Device Dislodged or Dislocated 1 1
Expulsion 1 1
Device Or Device Fragments Location Unknown 1 1
Material Separation 1 1
Sticking 1 1
Particulates 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 60 60
Pain 51 51
Red Eye(s) 50 50
Eye Pain 26 26
Eye Injury 24 24
Keratitis 23 23
Eye Infections 23 23
Blurred Vision 21 21
Unspecified Infection 21 21
Corneal Abrasion 20 20
Corneal Edema 18 18
Irritation 17 17
Corneal Scar 16 16
Visual Impairment 16 16
Corneal Infiltrates 16 16
Discomfort 16 16
Loss of Vision 14 14
Conjunctivitis 14 14
Excessive Tear Production 12 12
Inflammation 11 11
Acanthameba Keratitis 10 10
Burning Sensation 9 9
Discharge 9 9
Neovascularization 8 8
Foreign Body Sensation in Eye 8 8
Dry Eye(s) 7 7
Ulcer 7 7
Headache 6 6
Bacterial Infection 6 6
Iritis 6 6
Swelling 5 5
Erosion 5 5
Fungal Infection 5 5
Visual Disturbances 4 4
Itching Sensation 4 4
Hyphema 3 3
Purulent Discharge 3 3
Corneal Stromal Edema 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 2 2
Eye Burn 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2
Intraocular Pressure Decreased 2 2
Vomiting 2 2
Halo 2 2
Reaction 2 2
Corneal Clouding/Hazing 2 2
Hemorrhage/Bleeding 2 2
Hypopyon 2 2
Nausea 2 2
Laceration(s) 1 1
Uveitis 1 1
Staphylococcus Aureus 1 1
Infiltration into Tissue 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Erythema 1 1
Syncope 1 1
Abrasion 1 1
Abscess 1 1
Collapse 1 1
Coma 1 1
Loss of consciousness 1 1
Injury 1 1
Meningitis 1 1
Convulsion, Clonic 1 1
Unspecified Eye / Vision Problem 1 1
Patient Problem/Medical Problem 1 1
Fluid Discharge 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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