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	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	492	492
Insufficient Information	53	53
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
Defective Device	5	5
Scratched Material	5	5
Fitting Problem	4	4
Break	4	4
Patient-Device Incompatibility	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	264	264
Red Eye(s)	206	206
Eye Pain	189	189
Eye Infections	134	134
Keratitis	121	121
Foreign Body Sensation in Eye	116	116
Blurred Vision	91	91
Conjunctivitis	80	80
Bacterial Infection	79	79
Corneal Scar	68	68
Excessive Tear Production	65	65
Dry Eye(s)	48	48
Corneal Infiltrates	46	46
Local Reaction	45	45
Pain	44	44
Visual Disturbances	44	44
Corneal Abrasion	42	42
Eye Injury	38	38
Discomfort	36	36
Itching Sensation	36	36
Visual Impairment	25	25
Corneal Edema	24	24
Burning Sensation	23	23
Inflammation	22	22
Irritation	21	21
Acanthameba Keratitis	20	20
Swelling/ Edema	19	19
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	12	12
Hypersensitivity/Allergic reaction	10	10
Iritis	10	10
Fungal Infection	10	10
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
Abscess	6	6
Skin Inflammation/ Irritation	6	6
Insufficient Information	6	6
Erythema	6	6
Cellulitis	5	5
Erosion	5	5