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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, solution, ultrasonic cleaners for lenses
Regulation Description Soft (hydrophilic) contact lens care products.
Product CodeLYL
Regulation Number 886.5928
Device Class 2

MDR Year MDR Reports MDR Events
2016 6 6
2017 3 3
2018 5 5
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12 12
Patient-Device Incompatibility 2 2
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burning Sensation 7 7
Red Eye(s) 6 6
Unspecified Infection 5 5
Pain 4 4
Corneal Ulcer 3 3
Blurred Vision 3 3
Conjunctivitis 3 3
Dry Eye(s) 3 3
Corneal Abrasion 2 2
Inflammation 2 2
Irritation 2 2
Eye Injury 2 2
Itching Sensation 2 2
Keratitis 2 2
Acanthameba Keratitis 1 1
Neovascularization 1 1
Corneal Scar 1 1
Loss of Vision 1 1
Scar Tissue 1 1
Dizziness 1 1
Corneal Infiltrates 1 1
Discharge 1 1
Excessive Tear Production 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Corneal Edema 1 1
Vitreous Floaters 1 1
Burn(s) 1 1

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