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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
2018 32 32
2019 34 34
2020 32 32
2021 24 24
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 83 83
Insufficient Information 15 15
Defective Device 11 11
Improper or Incorrect Procedure or Method 9 9
Product Quality Problem 6 6
Patient-Device Incompatibility 6 6
Material Split, Cut or Torn 5 5
Break 4 4
Entrapment of Device 3 3
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
Expulsion 1 1
Fitting Problem 1 1
Component Missing 1 1
Sticking 1 1
Particulates 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 43 43
Pain 42 42
Red Eye(s) 41 41
Eye Injury 23 23
Keratitis 19 19
Eye Pain 18 18
Corneal Edema 17 17
Corneal Abrasion 16 16
Visual Impairment 16 16
Unspecified Infection 16 16
Corneal Infiltrates 15 15
Blurred Vision 14 14
Conjunctivitis 14 14
Irritation 14 14
Discomfort 13 13
Corneal Scar 13 13
Loss of Vision 12 12
Excessive Tear Production 10 10
Eye Infections 9 9
Discharge 9 9
Inflammation 9 9
Acanthameba Keratitis 7 7
Iritis 6 6
Dry Eye(s) 6 6
Swelling 5 5
Bacterial Infection 5 5
Ulcer 5 5
Fungal Infection 5 5
Burning Sensation 5 5
Headache 5 5
Itching Sensation 4 4
Neovascularization 4 4
Visual Disturbances 4 4
Foreign Body Sensation in Eye 3 3
Skin Inflammation/ Irritation 3 3
Hemorrhage/Bleeding 2 2
Corneal Stromal Edema 2 2
Halo 2 2
Hyphema 2 2
Corneal Clouding/Hazing 2 2
Purulent Discharge 2 2
Reaction 2 2
Device Embedded In Tissue or Plaque 2 2
Injury 1 1
Hypopyon 1 1
Vomiting 1 1
Laceration(s) 1 1
Erythema 1 1
Abscess 1 1
Coma 1 1
Unspecified Eye / Vision Problem 1 1
Hyperemia 1 1
Nausea 1 1
Convulsion, Clonic 1 1
Meningitis 1 1
Patient Problem/Medical Problem 1 1
Swelling/ Edema 1 1
Uveitis 1 1
Hypersensitivity/Allergic reaction 1 1
Abrasion 1 1
Erosion 1 1
Loss of consciousness 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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