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	25

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	546	549
Insufficient Information	61	61
Use of Device Problem	8	9
Improper or Incorrect Procedure or Method	8	9
No Apparent Adverse Event	7	7
Material Split, Cut or Torn	6	6
Defective Device	6	7
Scratched Material	5	5
Fitting Problem	4	4
Break	4	4
Patient-Device Incompatibility	4	5
Patient Device Interaction Problem	4	4
Nonstandard Device	4	4
Product Quality Problem	3	6
Material Disintegration	2	2
Difficult to Remove	2	2
Component Missing	2	2
Material Deformation	2	2
Appropriate Term/Code Not Available	2	3
Extra Components	2	2
Material Opacification	1	1
Manufacturing, Packaging or Shipping Problem	1	2
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	3
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	290	293
Red Eye(s)	231	232
Eye Pain	219	219
Eye Infections	153	153
Foreign Body Sensation in Eye	134	134
Keratitis	131	133
Blurred Vision	106	107
Conjunctivitis	91	91
Bacterial Infection	83	83
Corneal Scar	75	76
Excessive Tear Production	70	71
Dry Eye(s)	59	59
Corneal Infiltrates	48	49
Visual Disturbances	48	48
Local Reaction	45	45
Pain	44	46
Corneal Abrasion	44	48
Eye Injury	43	44
Itching Sensation	41	41
Discomfort	39	40
Visual Impairment	28	28
Swelling/ Edema	26	26
Corneal Edema	26	27
Burning Sensation	26	27
Inflammation	24	24
Acanthameba Keratitis	23	23
Irritation	21	21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	21
Unspecified Infection	16	16
Loss of Vision	16	18
Swelling	16	16
Headache	15	16
Hypersensitivity/Allergic reaction	14	14
Hypopyon	13	14
Unspecified Eye / Vision Problem	13	13
Iritis	12	12
Eye Burn	10	10
Fluid Discharge	10	11
Fungal Infection	10	10
Neovascularization	9	10
Discharge	9	9
Uveitis	9	9
Hyperemia	8	8
Corneal Clouding/Hazing	7	7
Erosion	7	7
Erythema	7	7
Skin Inflammation/ Irritation	6	6
Abscess	6	7
Insufficient Information	6	7
Caustic/Chemical Burns	5	5