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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device accessories, solution, ultrasonic cleaners for lenses
Regulation Description Soft (hydrophilic) contact lens care products.
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
2021 2 2
2022 3 3
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Product Quality Problem 1 1
Material Fragmentation 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Red Eye(s) 4 4
Burning Sensation 4 4
Eye Burn 3 3
Dry Eye(s) 3 3
Blurred Vision 3 3
Discomfort 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Eye Pain 2 2
Keratitis 2 2
Pain 2 2
Caustic/Chemical Burns 1 1
Aspiration/Inhalation 1 1
Corneal Ulcer 1 1
Erythema 1 1
Foreign Body Sensation in Eye 1 1
Corneal Clouding/Hazing 1 1
Hypopyon 1 1
Inflammation 1 1
Eye Infections 1 1
Uveitis 1 1
Visual Disturbances 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Family Dollar Stores, Llc. II Nov-07-2023
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