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)
2021	2022	2023	2024	2025	2026
28	40	15	31	31	16

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	497	499
Insufficient Information	73	73
Defective Device	12	13
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
Patient-Device Incompatibility	5	6
Patient Device Interaction Problem	5	5
Nonstandard Device	5	5
Fitting Problem	4	4
Break	4	4
Scratched Material	4	4
Material Deformation	3	3
Product Quality Problem	3	6
Material Disintegration	2	2
Material Integrity Problem	2	2
Failure to Clean Adequately	2	2
Difficult to Remove	2	2
Component Missing	2	2
Unexpected Therapeutic Results	2	2
Extra Components	2	2
Material Opacification	1	1
Unintended Movement	1	1
Manufacturing, Packaging or Shipping Problem	1	2
Contamination	1	1
Microbial Contamination of Device	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	3
Device Handling Problem	1	1
Unexpected Color	1	1
Material Separation	1	1
Failure to Unfold or Unwrap	1	1
Appropriate Term/Code Not Available	1	2
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Ulcer	268	270
Eye Pain	242	242
Red Eye(s)	219	220
Eye Infections	177	177
Foreign Body Sensation in Eye	135	135
Keratitis	118	119
Blurred Vision	110	110
Conjunctivitis	76	76
Corneal Scar	74	75
Excessive Tear Production	66	67
Dry Eye(s)	59	59
Bacterial Infection	52	52
Visual Disturbances	49	49
Corneal Infiltrates	47	47
Local Reaction	44	44
Corneal Abrasion	43	47
Eye Injury	41	41
Itching Sensation	41	41
Visual Impairment	33	33
Acanthameba Keratitis	31	31
Swelling/ Edema	30	30
Discomfort	30	30
Corneal Edema	24	24
Burning Sensation	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	22
Loss of Vision	18	20
Inflammation	18	18
Unspecified Eye / Vision Problem	17	17
Hypersensitivity/Allergic reaction	16	16
Headache	14	15
Erosion	14	14
Eye Burn	11	11
Hypopyon	11	11
Fungal Infection	9	9
Uveitis	9	9
Fluid Discharge	9	9
Iritis	9	9
Unspecified Infection	8	8
Neovascularization	8	8
Skin Inflammation/ Irritation	8	8
No Clinical Signs, Symptoms or Conditions	7	7
Hyperemia	7	7
Erythema	7	7
Pain	7	8
Corneal Clouding/Hazing	6	6
Insufficient Information	6	7
Cellulitis	5	5
Hyphema	5	5
Corneal Stromal Edema	5	5
Purulent Discharge	4	4