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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
1	1	0	4	7	2	3	6	5	9	6	6	6	5	6	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	997	8195
Malposition of Device	363	2925
Insufficient Information	201	201
Obstruction of Flow	157	2109
Break	109	5233
Device Dislodged or Dislocated	75	1295
Use of Device Problem	60	304
Patient-Device Incompatibility	50	50
Appropriate Term/Code Not Available	39	39
Device Operates Differently Than Expected	36	36
Migration or Expulsion of Device	34	34
Improper or Incorrect Procedure or Method	28	28
Positioning Problem	28	28
Contamination	18	628
Migration	17	17
Activation, Positioning or Separation Problem	11	11
Unexpected Therapeutic Results	10	10
Occlusion Within Device	10	10
Difficult to Insert	10	10
No Apparent Adverse Event	9	9
Defective Device	9	9
Nonstandard Device	8	8
Separation Failure	8	8
Therapeutic or Diagnostic Output Failure	8	8
Complete Blockage	7	7
Difficult or Delayed Positioning	6	6
Material Protrusion/Extrusion	6	6
Failure to Advance	6	6
Difficult to Advance	6	6
Difficult To Position	5	5
Patient Device Interaction Problem	5	127
Material Twisted/Bent	5	5
Unintended Movement	5	5
Entrapment of Device	5	5
Device Stenosis	4	4
Positioning Failure	4	4
Failure to Fire	4	4
Increase in Pressure	4	4
Device Or Device Fragments Location Unknown	4	4
Separation Problem	4	4
Optical Obstruction	4	4
Physical Resistance	3	3
Material Fragmentation	3	3
Unsealed Device Packaging	3	125
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	125
Fracture	3	125
Difficult or Delayed Activation	3	3
Failure to Eject	3	3
Component Falling	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	608	5489
Hyphema	318	4100
No Code Available	207	207
Foreign Body In Patient	195	3001
Eye Injury	183	305
Visual Impairment	183	2013
No Clinical Signs, Symptoms or Conditions	161	6627
Inflammation	160	1258
No Known Impact Or Consequence To Patient	142	264
Iritis	105	1081
Loss of Vision	91	457
Corneal Edema	85	939
Blurred Vision	83	205
Intraocular Pressure, Delayed, Uncontrolled	78	79
No Consequences Or Impact To Patient	77	1175
Pain	72	805
Macular Edema	62	428
Hemorrhage/Bleeding	51	51
Uveitis	49	659
Insufficient Information	48	292
Eye Pain	40	40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	40	162
Adhesion(s)	39	649
No Information	38	38
Endophthalmitis	35	889
Corneal Decompensation	32	32
Visual Disturbances	28	28
Failure of Implant	26	26
Intraocular Pressure Decreased	25	147
Vitreous Hemorrhage	23	23
Headache	21	21
Therapeutic Response, Decreased	19	19
Patient Problem/Medical Problem	14	14
Discomfort	13	13
Corneal Abrasion	12	12
Tissue Damage	12	12
Glaucoma	11	11
Capsular Bag Tear	11	133
Foreign Body Sensation in Eye	11	11
Red Eye(s)	10	133
Hypopyon	10	132
Dry Eye(s)	10	10
Corneal Clouding/Hazing	10	10
Fibrosis	10	10
Therapeutic Effects, Unexpected	9	9
Complaint, Ill-Defined	8	8
Scar Tissue	8	8
Vitrectomy	7	7
Device Embedded In Tissue or Plaque	7	7
No Patient Involvement	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Alcon Research, LTD.	I	Oct-23-2018