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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)
Regulation Description Soft (hydrophilic) contact lens.
Product CodeMVN
Regulation Number 886.5925
Device Class 2


Premarket Reviews
ManufacturerDecision
ALCON LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOYA LAMPHUN , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 32 32
2021 24 24
2022 18 20
2023 24 24
2024 25 25
2025 22 22
2026 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 91 91
Insufficient Device Problem Information 26 26
Material Split, Cut or Torn 15 15
No Apparent Adverse Event 4 4
Defective Device 3 3
Device Handling Problem 3 3
Patient-Device Incompatibility 2 2
Contamination 2 2
Difficult to Remove 2 2
Material Twisted/Bent 2 2
Product Quality Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Improper or Incorrect Procedure or Method 2 2
Material Frayed 1 1
Fitting Problem 1 1
Expulsion 1 1
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Component Missing 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 50 50
Eye Infections 45 45
Eye Pain 39 39
Red Eye(s) 32 34
Blurred Vision 19 19
Corneal Abrasion 19 19
Keratitis 19 19
Eye Irritation 19 21
Eye Injury 18 18
Corneal Scar 15 15
Corneal Infiltrates 13 13
Corneal Edema 13 13
Visual Impairment 11 11
Foreign Body Sensation in Eye 10 10
Burning Sensation 10 10
Erosion 9 9
Excessive Tear Production 8 8
Unspecified Infection 8 8
Inflammation 7 7
Conjunctivitis 7 7
Loss of Vision 6 6
Neovascularization 6 6
Headache 5 5
Infective Keratitis 5 5
Discomfort 5 5
Dry Eye(s) 5 5
Photophobia 5 5
Visual Disturbances 4 4
Pain 4 4
Fluid Discharge 4 4
Hyphema 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Bacterial Infection 4 4
Hyperemia 4 4
Corneal Stromal Edema 3 3
Local Reaction 3 3
Insufficient Information 3 3
Purulent Discharge 3 3
Skin Inflammation/ Irritation 3 3
Swelling/ Edema 3 3
Ulcer 3 3
Iritis 3 3
Hypersensitivity/Allergic reaction 3 3
Irritation 2 2
Eye Burn 2 2
Unspecified Eye / Vision Problem 2 4
Hemorrhage/Blood Loss/Bleeding 2 2
Itching Sensation 2 2
Abscess 2 2
Reaction 2 2

Recalls
Manufacturer Recall Class Date Posted
1 CooperVision, Inc. II Sep-19-2025
2 CooperVision, Inc. II Mar-26-2025
3 Johnson & Johnson Vision Care, Inc. II Apr-17-2020
4 Ontact Inc II Jul-05-2024
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