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)
2021	2022	2023	2024	2025	2026
6	5	6	4	4	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	437	7513
Malposition of Device	211	2773
Break	120	4878
Obstruction of Flow	89	2041
Device Dislodged or Dislocated	45	1265
Insufficient Device Problem Information	41	41
Difficult to Advance	40	40
Migration	34	34
Separation Failure	24	24
Contamination	16	504
Use of Device Problem	10	132
Retraction Problem	7	7
Defective Device	7	7
Device Stenosis	7	7
Migration or Expulsion of Device	5	5
Positioning Problem	4	4
Fracture	4	126
Failure to Eject	4	4
Difficult to Insert	3	3
Separation Problem	3	3
Complete Blockage	3	3
Lack of Effect	3	3
Material Twisted/Bent	3	3
Failure to Advance	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Detachment of Device or Device Component	2	2
Improper or Incorrect Procedure or Method	2	2
Particulates	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Mechanical Jam	1	1
Unsealed Device Packaging	1	123
Human-Device Interface Problem	1	1
Contamination /Decontamination Problem	1	123
Device Appears to Trigger Rejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	259	5139
No Clinical Signs, Symptoms or Conditions	228	6694
Hyphema	156	3938
Insufficient Information	102	224
Foreign Body In Patient	99	2905
Eye Injury	78	200
Inflammation	78	1176
Visual Impairment	78	1908
Macular Edema	59	425
Adhesion(s)	59	669
Corneal Edema	55	909
Blurred Vision	54	176
Eye Pain	47	47
Iritis	47	1023
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	41	163
Intraocular Pressure Decreased	32	154
Uveitis	31	641
Visual Disturbances	19	19
Endophthalmitis	17	871
Corneal Decompensation	17	17
Pain	14	746
Loss of Vision	13	379
Corneal Endothelial Cell Loss	12	12
Headache	10	10
Vitreous Hemorrhage	9	9
Capsular Bag Tear	9	131
Fibrosis	8	8
Dry Eye(s)	8	8
Hypersensitivity/Allergic reaction	8	8
UGH (Uveitis Glaucoma Hyphema) Syndrome	7	7
Foreign Body Sensation in Eye	7	7
Red Eye(s)	6	128
Glaucoma	6	6
No Consequences Or Impact To Patient	6	494
Eye Infections	5	127
Corneal Clouding/Hazing	5	5
Prolapse	5	5
Failure of Implant	5	5
Fluid Discharge	5	5
Scar Tissue	5	5
Eye Irritation	5	127
Device Embedded In Tissue or Plaque	4	4
Vitreous Floaters	4	4
Hemorrhage/Blood Loss/Bleeding	4	4
No Known Impact Or Consequence To Patient	4	126
Keratitis	4	126
Hypopyon	4	126
Swelling/ Edema	4	4
Excessive Tear Production	4	4
Discomfort	3	3