TPLC - Total Product Life Cycle

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Device	lenses, soft contact, extended wear
Regulation Description	Soft (hydrophilic) contact lens.
Product Code	LPM
Regulation Number	886.5925
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
45	28	40	15	31	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	481	481
Insufficient Information	53	53
Use of Device Problem	7	7
No Apparent Adverse Event	6	6
Material Split, Cut or Torn	5	5
Defective Device	5	5
Scratched Material	5	5
Fitting Problem	4	4
Break	4	4
Patient-Device Incompatibility	4	4
Improper or Incorrect Procedure or Method	4	4
Product Quality Problem	3	3
Material Disintegration	2	2
Difficult to Remove	2	2
Patient Device Interaction Problem	2	2
Component Missing	2	2
Appropriate Term/Code Not Available	2	2
Nonstandard Device	2	2
Extra Components	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Material Discolored	1	1
Material Deformation	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	259	259
Red Eye(s)	201	201
Eye Pain	182	182
Eye Infections	127	127
Keratitis	121	121
Foreign Body Sensation in Eye	115	115
Blurred Vision	87	87
Bacterial Infection	79	79
Conjunctivitis	79	79
Corneal Scar	68	68
Excessive Tear Production	64	64
Dry Eye(s)	48	48
Corneal Infiltrates	46	46
Local Reaction	45	45
Pain	44	44
Visual Disturbances	43	43
Corneal Abrasion	42	42
Eye Injury	37	37
Discomfort	36	36
Itching Sensation	34	34
Corneal Edema	24	24
Visual Impairment	24	24
Burning Sensation	23	23
Irritation	21	21
Swelling/ Edema	19	19
Acanthameba Keratitis	19	19
Inflammation	18	18
Unspecified Infection	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	16	16
Loss of Vision	16	16
Swelling	16	16
Headache	14	14
Hypopyon	11	11
Hypersensitivity/Allergic reaction	10	10
Fungal Infection	10	10
Iritis	9	9
Discharge	9	9
Unspecified Eye / Vision Problem	9	9
Hyperemia	8	8
Fluid Discharge	8	8
Corneal Clouding/Hazing	7	7
Eye Burn	7	7
Neovascularization	7	7
Uveitis	6	6
Skin Inflammation/ Irritation	6	6
Erythema	6	6
Insufficient Information	6	6
Abscess	6	6
Erosion	5	5
Hyphema	5	5