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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
Product CodeLYL
Regulation Number 886.5928
Device Class 2


Premarket Reviews
ManufacturerDecision
SUZHOU 3N BIOLOGICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
VUESONIC, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 5 5
2019 1 1
2021 2 2
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7 7
Insufficient Information 2 2
Product Quality Problem 1 1
Material Fragmentation 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Corneal Ulcer 3 3
Pain 3 3
Burning Sensation 3 3
Blurred Vision 3 3
Red Eye(s) 2 2
Dry Eye(s) 2 2
Inflammation 2 2
Unspecified Infection 2 2
Keratitis 2 2
Acanthameba Keratitis 1 1
Neovascularization 1 1
Corneal Scar 1 1
Itching Sensation 1 1
Eye Injury 1 1
Hypopyon 1 1
Dizziness 1 1
Corneal Infiltrates 1 1
Discomfort 1 1
Erythema 1 1
Excessive Tear Production 1 1
Ambulation Difficulties 1 1
Caustic/Chemical Burns 1 1
Eye Infections 1 1
Irritation 1 1
Conjunctivitis 1 1
Corneal Abrasion 1 1
Corneal Edema 1 1
Foreign Body Sensation in Eye 1 1
Eye Burn 1 1

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