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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
2019 34 34
2020 32 32
2021 24 24
2022 18 18
2023 24 24
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 96 96
Insufficient Information 15 15
Defective Device 11 11
Material Split, Cut or Torn 10 10
Improper or Incorrect Procedure or Method 8 8
Patient-Device Incompatibility 5 5
Break 4 4
Product Quality Problem 4 4
Entrapment of Device 3 3
Material Rupture 2 2
Use of Device Problem 2 2
Expiration Date Error 2 2
Fitting Problem 1 1
Packaging Problem 1 1
Expulsion 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 40 40
Corneal Ulcer 39 39
Eye Pain 28 28
Eye Infections 26 26
Pain 22 22
Keratitis 22 22
Eye Injury 21 21
Blurred Vision 18 18
Corneal Scar 15 15
Corneal Abrasion 14 14
Visual Impairment 14 14
Corneal Edema 13 13
Unspecified Infection 13 13
Corneal Infiltrates 12 12
Excessive Tear Production 10 10
Discomfort 8 8
Conjunctivitis 8 8
Foreign Body Sensation in Eye 8 8
Dry Eye(s) 7 7
Irritation 7 7
Neovascularization 7 7
Burning Sensation 7 7
Loss of Vision 6 6
Headache 6 6
Bacterial Infection 5 5
Erosion 5 5
Inflammation 5 5
Iritis 4 4
Hyphema 4 4
Acanthameba Keratitis 4 4
Discharge 4 4
Visual Disturbances 3 3
Ulcer 3 3
Fluid Discharge 3 3
Skin Inflammation/ Irritation 3 3
Itching Sensation 3 3
Purulent Discharge 3 3
Corneal Stromal Edema 3 3
Corneal Clouding/Hazing 2 2
Hemorrhage/Bleeding 2 2
Hypopyon 2 2
Swelling/ Edema 2 2
Eye Burn 2 2
Device Embedded In Tissue or Plaque 2 2
Intraocular Pressure Decreased 2 2
Reaction 2 2
Halo 2 2
Convulsion, Clonic 1 1
Vomiting 1 1
Coma 1 1
Loss of consciousness 1 1
Fungal Infection 1 1
Injury 1 1
Meningitis 1 1
Unspecified Eye / Vision Problem 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Infiltration into Tissue 1 1
Laceration(s) 1 1
Nausea 1 1
Swelling 1 1
Uveitis 1 1
Hyperemia 1 1
Hypersensitivity/Allergic reaction 1 1
Erythema 1 1
Abscess 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Vision Care, Inc. II Apr-17-2020
2 Ontact Inc II Jul-05-2024
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