TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
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	813	813
No Apparent Adverse Event	404	404
Insufficient Information	122	122
Patient-Device Incompatibility	29	29
Improper or Incorrect Procedure or Method	17	17
Appropriate Term/Code Not Available	13	13
Device Operates Differently Than Expected	10	10
Defective Device	10	10
Use of Device Problem	10	10
Torn Material	8	8
Fitting Problem	6	6
Scratched Material	6	6
Difficult to Remove	5	5
Microbial Contamination of Device	5	5
Material Split, Cut or Torn	4	4
Break	3	3
Device Contamination with Chemical or Other Material	3	3
Material Integrity Problem	3	3
Product Quality Problem	3	3
Sticking	2	2
Inadequacy of Device Shape and/or Size	2	2
Device Handling Problem	2	2
Component Missing	2	2
Contamination /Decontamination Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Component	2	2
Fogging	1	1
Shelf Life Exceeded	1	1
Degraded	1	1
Patient Device Interaction Problem	1	1
Material Discolored	1	1
Device Packaging Compromised	1	1
Contamination	1	1
Out-Of-Box Failure	1	1
Device Unsafe to Use in Environment	1	1
Unexpected Color	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Failure to Unfold or Unwrap	1	1
Tear, Rip or Hole in Device Packaging	1	1
Peeled/Delaminated	1	1
Material Opacification	1	1
Entrapment of Device	1	1
Nonstandard Device	1	1
Unexpected Therapeutic Results	1	1
Optical Discoloration	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Detachment Of Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	626	626
Red Eye(s)	598	598
Pain	387	387
Keratitis	301	301
Bacterial Infection	255	255
Discomfort	243	243
Irritation	240	240
Conjunctivitis	197	197
Unspecified Infection	177	177
Excessive Tear Production	176	176
Blurred Vision	169	169
Foreign Body Sensation in Eye	166	166
Eye Pain	153	153
Swelling	137	137
Corneal Scar	126	126
Itching Sensation	123	123
Discharge	121	121
Dry Eye(s)	117	117
Burning Sensation	115	115
Corneal Abrasion	108	108
Corneal Infiltrates	106	106
Eye Infections	99	99
Inflammation	83	83
Loss of Vision	77	77
Eye Injury	65	65
Corneal Edema	48	48
Visual Impairment	48	48
Visual Disturbances	48	48
Acanthameba Keratitis	41	41
Local Reaction	38	38
Iritis	37	37
Fungal Infection	23	23
Neovascularization	21	21
Intraocular Infection	20	20
Hypopyon	19	19
Swelling/ Edema	19	19
Headache	17	17
Scar Tissue	16	16
Corneal Clouding/Hazing	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
No Code Available	13	13
Abscess	13	13
Ulcer	12	12
Uveitis	11	11
Erosion	11	11
Erythema	11	11
Fluid Discharge	11	11
Hyperemia	10	10
Hypersensitivity/Allergic reaction	10	10
Scarring	8	8

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