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)
2019	2020	2021	2022	2023	2024
55	45	28	40	15	28

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	633	633
Insufficient Information	52	52
Defective Device	7	7
Use of Device Problem	7	7
No Apparent Adverse Event	6	6
Improper or Incorrect Procedure or Method	6	6
Material Split, Cut or Torn	5	5
Patient-Device Incompatibility	5	5
Scratched Material	5	5
Fitting Problem	4	4
Product Quality Problem	3	3
Appropriate Term/Code Not Available	3	3
Break	2	2
Difficult to Remove	2	2
Patient Device Interaction Problem	2	2
Component Missing	2	2
Nonstandard Device	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Material Discolored	1	1
Device Handling Problem	1	1
Unexpected Color	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Failure to Unfold or Unwrap	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	345	345
Red Eye(s)	282	282
Eye Pain	163	163
Keratitis	155	155
Foreign Body Sensation in Eye	119	119
Eye Infections	118	118
Pain	108	108
Bacterial Infection	107	107
Corneal Scar	94	94
Conjunctivitis	93	93
Blurred Vision	88	88
Excessive Tear Production	83	83
Discomfort	82	82
Dry Eye(s)	62	62
Irritation	62	62
Corneal Infiltrates	54	54
Corneal Abrasion	48	48
Itching Sensation	47	47
Burning Sensation	46	46
Visual Disturbances	43	43
Unspecified Infection	42	42
Local Reaction	41	41
Eye Injury	39	39
Swelling	37	37
Inflammation	34	34
Visual Impairment	32	32
Discharge	31	31
Corneal Edema	30	30
Loss of Vision	19	19
Swelling/ Edema	19	19
Acanthameba Keratitis	19	19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Headache	14	14
Fungal Infection	12	12
Neovascularization	12	12
Iritis	11	11
Hypopyon	11	11
Corneal Clouding/Hazing	10	10
Hypersensitivity/Allergic reaction	10	10
Hyperemia	8	8
Abscess	8	8
Unspecified Eye / Vision Problem	8	8
No Code Available	7	7
Fluid Discharge	7	7
Uveitis	6	6
Insufficient Information	6	6
Skin Inflammation/ Irritation	6	6
Corneal Pannus	5	5
Nausea	5	5
Eye Burn	5	5