TPLC - Total Product Life Cycle

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Device	lenses, soft contact, daily wear
Regulation Description	Soft (hydrophilic) contact lens.
Product Code	LPL
Regulation Number	886.5925
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALCON LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	8
ART OPTICAL CONTACT LENS, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAUSCH & LOMB INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
BAUSCH + LOMB, INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BENQ MATERIALS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BRUNO VISION CARE, LLC
	SUBSTANTIALLY EQUIVALENT	2
COOPERVISION, INC.
	SUBSTANTIALLY EQUIVALENT	3
DK MEDIVISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
E.O.S CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOYA LAMPHUN , LTD.
	SUBSTANTIALLY EQUIVALENT	1
HUNAN HAIPUMING TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INNOVA VISION, INC.
	SUBSTANTIALLY EQUIVALENT	4
INTEROJO, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON VISION CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
LARGAN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
LUCENS TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
METRO OPTICS OF AUSTIN, INC.
	SUBSTANTIALLY EQUIVALENT	1
PEGAVISION CORPORATION
	SUBSTANTIALLY EQUIVALENT	6
SHENZHEN DASHICHENG OPTICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ST. SHINE OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
UNICON OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
VIZIONFOCUS, INC.
	SUBSTANTIALLY EQUIVALENT	3
VP OPTICS
	SUBSTANTIALLY EQUIVALENT	1
X-CEL SPECIALTY CONTACTS, A WALMAN OPTICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
YUNG SHENG OPTICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	613	615
Material Split, Cut or Torn	43	47
Improper or Incorrect Procedure or Method	42	42
Insufficient Information	22	22
Patient-Device Incompatibility	21	21
Product Quality Problem	21	24
Difficult to Remove	21	24
Use of Device Problem	17	17
Patient Device Interaction Problem	14	14
Therapeutic or Diagnostic Output Failure	10	10
Break	7	24
Device Handling Problem	7	7
Contamination	7	7
Fitting Problem	6	6
Entrapment of Device	6	23
Nonstandard Device	6	7
Crack	6	9
Defective Device	6	13
Manufacturing, Packaging or Shipping Problem	5	5
Material Deformation	5	5
Material Twisted/Bent	5	5
Material Opacification	4	4
Device Contaminated During Manufacture or Shipping	3	4
Device Markings/Labelling Problem	3	3
Material Puncture/Hole	3	3
Expiration Date Error	3	3
Microbial Contamination of Device	3	3
Contamination /Decontamination Problem	3	3
Material Too Rigid or Stiff	3	3
Component Missing	3	3
Particulates	3	3
Difficult to Open or Close	2	2
Appropriate Term/Code Not Available	2	2
Tear, Rip or Hole in Device Packaging	2	2
Inadequacy of Device Shape and/or Size	2	2
Unexpected Color	2	2
Sharp Edges	2	2
Material Frayed	2	2
Material Discolored	1	1
Dent in Material	1	1
Positioning Failure	1	1
Degraded	1	1
Failure to Clean Adequately	1	1
Defective Component	1	1
Wrong Label	1	8
Device Unsafe to Use in Environment	1	1
Material Invagination	1	1
Difficult to Fold, Unfold or Collapse	1	1
Material Disintegration	1	2
Peeled/Delaminated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	416	417
Eye Pain	343	347
Red Eye(s)	275	275
Blurred Vision	160	160
Foreign Body Sensation in Eye	152	154
Eye Infections	130	131
Keratitis	117	118
Conjunctivitis	100	100
Dry Eye(s)	97	97
Corneal Abrasion	96	96
Excessive Tear Production	88	88
Corneal Scar	87	87
Bacterial Infection	64	64
Eye Injury	57	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	52
Local Reaction	47	47
Corneal Infiltrates	44	45
Discomfort	44	45
Visual Disturbances	44	45
Eye Burn	42	42
Swelling/ Edema	40	41
Loss of Vision	36	36
Unspecified Eye / Vision Problem	35	35
Burning Sensation	28	28
Itching Sensation	27	27
Inflammation	26	26
Corneal Edema	24	24
Visual Impairment	24	25
Purulent Discharge	22	22
Hypersensitivity/Allergic reaction	22	22
Insufficient Information	21	21
Acanthameba Keratitis	20	20
Erosion	20	20
Headache	19	20
Uveitis	17	17
No Clinical Signs, Symptoms or Conditions	17	26
Iritis	14	14
Chemosis	13	13
Fungal Infection	13	13
Pain	12	12
Unspecified Infection	11	11
Increased Sensitivity	10	10
Foreign Body In Patient	10	14
Corneal Clouding/Hazing	9	10
Hypopyon	9	9
Erythema	8	8
Neovascularization	8	8
Fluid Discharge	6	6
Ulcer	5	6
Intraocular Infection	5	5

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research LLC	II	Oct-24-2025
2	Alcon Research LLC	II	Sep-30-2024
3	Clerio Vision	II	Apr-05-2021
4	Clerio Vision	II	Jan-08-2021
5	CooperVision Inc.	II	Jul-27-2021
6	CooperVision, Inc.	II	Mar-23-2023
7	CooperVision, Inc.	II	Jan-24-2023
8	Johnson & Johnson Vision Care, Inc.	II	Jul-23-2025
9	Johnson & Johnson Vision Care, Inc.	II	Jun-16-2021