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	470	7669
Malposition of Device	235	2797
Break	127	5251
Obstruction of Flow	95	2047
Insufficient Information	59	59
Device Dislodged or Dislocated	48	1268
Migration	30	30
Use of Device Problem	22	266
Contamination	20	630
Separation Failure	8	8
Defective Device	8	8
Migration or Expulsion of Device	7	7
Positioning Problem	7	7
Difficult to Advance	7	7
Patient-Device Incompatibility	6	6
Device Stenosis	6	6
Fracture	5	127
Nonstandard Device	4	4
Failure to Eject	4	4
Separation Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Material Twisted/Bent	4	4
Failure to Advance	4	4
Complete Blockage	3	3
Appropriate Term/Code Not Available	3	3
Difficult to Insert	3	3
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	2	2
Lack of Effect	2	2
Biocompatibility	2	2
Therapeutic or Diagnostic Output Failure	2	2
Contamination /Decontamination Problem	2	124
Activation, Positioning or Separation Problem	2	2
Retraction Problem	2	2
Material Deformation	1	1
Human-Device Interface Problem	1	1
Firing Problem	1	1
Particulates	1	1
Mechanical Jam	1	1
Power Problem	1	1
Difficult or Delayed Activation	1	1
Difficult to Open or Close	1	1
Unsealed Device Packaging	1	123
Device Appears to Trigger Rejection	1	1
Excess Flow or Over-Infusion	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	292	5172
No Clinical Signs, Symptoms or Conditions	194	6660
Hyphema	171	3953
Foreign Body In Patient	118	2924
Eye Injury	94	216
Inflammation	92	1190
Visual Impairment	88	1918
Insufficient Information	71	315
Corneal Edema	64	918
Iritis	62	1038
Blurred Vision	57	180
Macular Edema	56	422
Adhesion(s)	51	661
Eye Pain	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	41	163
Uveitis	39	649
No Consequences Or Impact To Patient	37	1013
Intraocular Pressure Decreased	32	154
Loss of Vision	22	388
Endophthalmitis	19	873
Visual Disturbances	18	18
Pain	17	749
Corneal Decompensation	15	15
No Known Impact Or Consequence To Patient	14	136
No Code Available	13	13
Vitreous Hemorrhage	10	10
Headache	10	10
Capsular Bag Tear	10	132
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
Corneal Clouding/Hazing	6	6
Hemorrhage/Bleeding	6	6
Scar Tissue	6	6
Eye Infections	5	127
Failure of Implant	5	5
Fluid Discharge	5	5
Hypopyon	5	127
Discomfort	5	5
Excessive Tear Production	5	5
Itching Sensation	5	5
Vitreous Floaters	4	4
Swelling/ Edema	4	4
Corneal Abrasion	4	4
Device Embedded In Tissue or Plaque	4	4
Therapeutic Response, Decreased	4	4