TPLC - Total Product Life Cycle

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Device	lenses, soft contact, extended wear
Product Code	LPM
Regulation Number	886.5925
Device Class	3

Premarket Approvals (PMA)
2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
26	35	43	79	59	55	45	28	40	15	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	876	876
No Apparent Adverse Event	406	406
Insufficient Information	144	144
Patient-Device Incompatibility	29	29
Improper or Incorrect Procedure or Method	21	21
Device Operates Differently Than Expected	17	17
Torn Material	13	13
Appropriate Term/Code Not Available	13	13
Use of Device Problem	12	12
Defective Device	11	11
Difficult to Remove	7	7
Scratched Material	6	6
Fitting Problem	6	6
Microbial Contamination of Device	5	5
Contamination	4	4
Material Split, Cut or Torn	4	4
Device Contamination with Chemical or Other Material	4	4
Break	3	3
Material Integrity Problem	3	3
Product Quality Problem	3	3
Defective Component	2	2
Contamination /Decontamination Problem	2	2
Device Handling Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Split	2	2
Component Missing	2	2
Sticking	2	2
Inadequacy of Device Shape and/or Size	2	2
Nonstandard Device	1	1
Unexpected Therapeutic Results	1	1
Optical Discoloration	1	1
Peeled/Delaminated	1	1
Device Markings/Labelling Problem	1	1
Entrapment of Device	1	1
Material Opacification	1	1
Failure to Unfold or Unwrap	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Labelling, Instructions for Use or Training Problem	1	1
Missing Value Reason	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Out-Of-Box Failure	1	1
Positioning Problem	1	1
Device Packaging Compromised	1	1
Material Discolored	1	1
Shelf Life Exceeded	1	1
Degraded	1	1
Fogging	1	1
Component Falling	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	688	688
Red Eye(s)	617	617
Pain	427	427
Keratitis	313	313
Bacterial Infection	262	262
Discomfort	255	255
Irritation	248	248
Unspecified Infection	199	199
Conjunctivitis	199	199
Excessive Tear Production	178	178
Blurred Vision	175	175
Foreign Body Sensation in Eye	168	168
Eye Pain	153	153
Swelling	143	143
Corneal Scar	143	143
Itching Sensation	128	128
Discharge	126	126
Burning Sensation	118	118
Corneal Abrasion	118	118
Dry Eye(s)	118	118
Corneal Infiltrates	115	115
Eye Infections	99	99
Inflammation	86	86
Loss of Vision	83	83
Eye Injury	68	68
Visual Impairment	55	55
Visual Disturbances	51	51
Corneal Edema	49	49
Acanthameba Keratitis	41	41
Iritis	39	39
Local Reaction	38	38
Fungal Infection	26	26
Neovascularization	25	25
Intraocular Infection	23	23
No Code Available	20	20
Swelling/ Edema	19	19
Hypopyon	19	19
Headache	17	17
Corneal Clouding/Hazing	17	17
Scar Tissue	16	16
Abscess	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Hyperemia	14	14
Erosion	14	14
Erythema	13	13
Ulcer	12	12
Uveitis	12	12
Fluid Discharge	12	12
Hypersensitivity/Allergic reaction	11	11
Complaint, Ill-Defined	10	10

Recalls
Manufacturer		Recall Class	Date Posted
1	Allied Vision Group Inc	II	Apr-29-2020
2	Cooper Vision Caribbean Corp.	II	Dec-15-2014
3	CooperVision Inc.	II	Jan-27-2020
4	CooperVision Inc.	III	Feb-23-2018
5	CooperVision, Inc.	II	Mar-01-2023
6	Intertrade Imports Inc.	II	Jan-12-2015
7	Johnson & Johnson Vision Care, Inc.	II	Mar-27-2018
8	Lens.com	II	Dec-05-2019