TPLC - Total Product Life Cycle

• Device: accessories, solution, ultrasonic cleaners for lenses
• Regulation Description: Soft (hydrophilic) contact lens care products.
• Product Code: LYL
• Regulation Number: 886.5928
• Device Class: 2

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

MDR Year	MDR Reports	MDR Events
2019	1	1
2021	2	2
2022	3	3
2023	5	5
2024	5	5
2025	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	8	8
Patient-Device Incompatibility	2	2
Insufficient Information	2	2
Patient Device Interaction Problem	1	1
Material Fragmentation	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Red Eye(s)	5	5
Burning Sensation	4	4
Blurred Vision	4	4
Dry Eye(s)	3	3
Keratitis	3	3
Eye Burn	3	3
Pain	3	3
Eye Pain	3	3
Foreign Body Sensation in Eye	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Inflammation	2	2
Acanthameba Keratitis	2	2
Corneal Ulcer	2	2
Visual Disturbances	2	2
Discomfort	2	2
Corneal Infiltrates	2	2
Excessive Tear Production	2	2
Corneal Clouding/Hazing	1	1
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Hypopyon	1	1
Corneal Abrasion	1	1
Aspiration/Inhalation	1	1
Neovascularization	1	1
Conjunctivitis	1	1
Erythema	1	1
Visual Impairment	1	1
Eye Infections	1	1
Corneal Edema	1	1
Caustic/Chemical Burns	1	1
Corneal Scar	1	1
Low Oxygen Saturation	1	1
Uveitis	1	1

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