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	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	598	598
Insufficient Information	49	49
Defective Device	7	7
Use of Device Problem	7	7
No Apparent Adverse Event	6	6
Improper or Incorrect Procedure or Method	6	6
Patient-Device Incompatibility	5	5
Fitting Problem	4	4
Material Split, Cut or Torn	4	4
Scratched Material	4	4
Product Quality Problem	3	3
Appropriate Term/Code Not Available	3	3
Break	2	2
Difficult to Remove	2	2
Component Missing	2	2
Therapeutic or Diagnostic Output Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient Device Interaction Problem	1	1
Contamination /Decontamination Problem	1	1
Microbial Contamination of Device	1	1
Degraded	1	1
Material Discolored	1	1
Unexpected Color	1	1
Device Handling Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Material Separation	1	1
Failure to Unfold or Unwrap	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	334	334
Red Eye(s)	271	271
Eye Pain	153	153
Keratitis	149	149
Foreign Body Sensation in Eye	116	116
Pain	108	108
Bacterial Infection	107	107
Eye Infections	99	99
Corneal Scar	91	91
Conjunctivitis	90	90
Blurred Vision	84	84
Excessive Tear Production	81	81
Discomfort	78	78
Irritation	62	62
Dry Eye(s)	56	56
Corneal Infiltrates	52	52
Itching Sensation	46	46
Corneal Abrasion	43	43
Visual Disturbances	43	43
Burning Sensation	42	42
Unspecified Infection	42	42
Eye Injury	39	39
Local Reaction	38	38
Swelling	37	37
Inflammation	34	34
Discharge	31	31
Corneal Edema	28	28
Visual Impairment	27	27
Swelling/ Edema	19	19
Acanthameba Keratitis	18	18
Loss of Vision	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Fungal Infection	12	12
Neovascularization	12	12
Hypopyon	11	11
Iritis	11	11
Headache	10	10
Corneal Clouding/Hazing	10	10
Hyperemia	8	8
No Code Available	7	7
Hypersensitivity/Allergic reaction	7	7
Fluid Discharge	7	7
Abscess	7	7
Unspecified Eye / Vision Problem	7	7
Uveitis	6	6
Insufficient Information	6	6
Skin Inflammation/ Irritation	6	6
Eye Burn	5	5
Corneal Stromal Edema	4	4
Erythema	4	4