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	7
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	609	611
Improper or Incorrect Procedure or Method	41	41
Material Split, Cut or Torn	39	43
Insufficient Information	22	22
Product Quality Problem	21	24
Patient-Device Incompatibility	20	20
Difficult to Remove	17	20
Use of Device Problem	17	17
Therapeutic or Diagnostic Output Failure	10	10
Patient Device Interaction Problem	9	9
Break	7	24
Device Handling Problem	7	7
Entrapment of Device	6	23
Nonstandard Device	6	7
Fitting Problem	5	5
Material Deformation	5	5
Defective Device	5	12
Manufacturing, Packaging or Shipping Problem	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
Particulates	3	3
Microbial Contamination of Device	3	3
Contamination /Decontamination Problem	3	3
Material Too Rigid or Stiff	3	3
Component Missing	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
Contamination	2	2
Material Frayed	2	2
Degraded	1	1
Positioning Failure	1	1
Material Discolored	1	1
Dent in Material	1	1
Failure to Clean Adequately	1	1
Defective Component	1	1
Wrong Label	1	8
Material Invagination	1	1
Device Unsafe to Use in Environment	1	1
Difficult to Fold, Unfold or Collapse	1	1
Material Disintegration	1	2
Peeled/Delaminated	1	1
Device Damaged Prior to Use	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	413	414
Eye Pain	336	340
Red Eye(s)	273	273
Blurred Vision	159	159
Foreign Body Sensation in Eye	150	152
Eye Infections	129	130
Keratitis	117	118
Conjunctivitis	99	99
Dry Eye(s)	96	96
Corneal Abrasion	91	91
Excessive Tear Production	88	88
Corneal Scar	87	87
Bacterial Infection	63	63
Eye Injury	57	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	47	51
Local Reaction	47	47
Discomfort	44	45
Corneal Infiltrates	43	44
Eye Burn	42	42
Swelling/ Edema	40	41
Visual Disturbances	39	40
Loss of Vision	36	36
Unspecified Eye / Vision Problem	35	35
Itching Sensation	27	27
Burning Sensation	27	27
Inflammation	26	26
Corneal Edema	24	24
Visual Impairment	24	25
Purulent Discharge	22	22
Hypersensitivity/Allergic reaction	22	22
Acanthameba Keratitis	20	20
Erosion	20	20
Insufficient Information	20	20
Headache	19	20
Uveitis	17	17
No Clinical Signs, Symptoms or Conditions	17	26
Iritis	13	13
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
Neovascularization	8	8
Erythema	8	8
Fluid Discharge	6	6
Intraocular Infection	5	5
Ulcer	5	6

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