TPLC - Total Product Life Cycle

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Device	intraocular pressure lowering implant
Definition	An intraocular pressure lowering implant is a device intended to reduce intraocular pressure when implanted in eyes which have not failed conventional medical and surgical treatment.
Product Code	OGO
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
6	6	5	6	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	440	7638
Malposition of Device	219	2781
Break	121	5245
Obstruction of Flow	94	2046
Insufficient Information	59	59
Device Dislodged or Dislocated	46	1266
Use of Device Problem	22	266
Migration	22	22
Contamination	19	629
Defective Device	7	7
Separation Failure	7	7
Positioning Problem	7	7
Migration or Expulsion of Device	7	7
Patient-Device Incompatibility	6	6
Difficult to Advance	5	5
Device Stenosis	5	5
Failure to Eject	4	4
Separation Problem	4	4
Nonstandard Device	4	4
Failure to Advance	4	4
Material Twisted/Bent	4	4
Fracture	4	126
Improper or Incorrect Procedure or Method	4	4
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Difficult to Insert	3	3
Complete Blockage	3	3
Lack of Effect	2	2
Biocompatibility	2	2
Contamination /Decontamination Problem	2	124
Activation, Positioning or Separation Problem	2	2
Patient Device Interaction Problem	1	1
Firing Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Excess Flow or Over-Infusion	1	1
Power Problem	1	1
Unsealed Device Packaging	1	123
Particulates	1	1
Device Appears to Trigger Rejection	1	1
Retraction Problem	1	1
Mechanical Jam	1	1
Difficult or Delayed Activation	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Difficult to Open or Close	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	279	5159
No Clinical Signs, Symptoms or Conditions	185	6651
Hyphema	158	3940
Foreign Body In Patient	113	2919
Eye Injury	89	211
Inflammation	86	1184
Visual Impairment	84	1914
Corneal Edema	60	914
Insufficient Information	59	303
Iritis	58	1034
Blurred Vision	53	175
Macular Edema	50	416
Adhesion(s)	46	656
Eye Pain	44	44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	39	161
No Consequences Or Impact To Patient	37	1013
Uveitis	37	647
Intraocular Pressure Decreased	30	152
Loss of Vision	22	388
Endophthalmitis	19	873
Visual Disturbances	17	17
Pain	17	749
Corneal Decompensation	15	15
No Known Impact Or Consequence To Patient	14	136
No Code Available	13	13
Headache	10	10
Vitreous Hemorrhage	9	9
Dry Eye(s)	8	8
Foreign Body Sensation in Eye	7	7
Hypersensitivity/Allergic reaction	7	7
UGH (Uveitis Glaucoma Hyphema) Syndrome	7	7
Capsular Bag Tear	7	129
Scar Tissue	6	6
Red Eye(s)	6	128
Hemorrhage/Bleeding	6	6
Corneal Clouding/Hazing	6	6
Glaucoma	6	6
Failure of Implant	5	5
Itching Sensation	5	5
Excessive Tear Production	5	5
Hypopyon	5	127
Discomfort	5	5
Eye Infections	5	127
Fluid Discharge	5	5
Swelling/ Edema	4	4
Keratitis	4	126
Therapeutic Response, Decreased	4	4
Corneal Abrasion	4	4
Device Embedded In Tissue or Plaque	4	4
Intraocular Pressure, Delayed, Uncontrolled	3	3