TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ALLERGAN, INC.
	SUBSTANTIALLY EQUIVALENT	1
GLAUKOS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE OPHTHALMIC PRODUCTS, INC. (IOP)
	SUBSTANTIALLY EQUIVALENT	1
NEW WORLD MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1299	1676
Complete Blockage	324	327
Malposition of Device	241	363
Physical Resistance/Sticking	228	228
Migration	131	131
Device Operates Differently Than Expected	108	108
Device Appears to Trigger Rejection	99	99
Appropriate Term/Code Not Available	95	105
Fracture	91	91
Mechanical Jam	90	90
Insufficient Information	81	81
Obstruction of Flow	65	65
Device Dislodged or Dislocated	53	176
Material Twisted/Bent	52	52
Partial Blockage	49	49
No Flow	48	48
Break	47	55
Retraction Problem	33	33
Failure to Deliver	32	32
Activation, Positioning or Separation Problem	31	31
Off-Label Use	29	29
Improper or Incorrect Procedure or Method	25	25
Device Issue	24	24
Migration or Expulsion of Device	24	24
Occlusion Within Device	22	22
Physical Property Issue	20	20
Failure to Eject	19	19
Defective Component	17	17
Positioning Failure	16	16
Patient-Device Incompatibility	16	16
Expiration Date Error	15	15
Device Markings/Labelling Problem	14	14
Positioning Problem	14	14
Defective Device	14	14
Use of Device Problem	13	13
Leak/Splash	12	12
Filtration Problem	11	11
Dull, Blunt	10	10
Material Erosion	10	10
No Apparent Adverse Event	10	10
Inadequate Filtration Process	9	9
Separation Failure	9	9
Infusion or Flow Problem	9	9
Material Deformation	9	9
Unintended Movement	8	8
Therapeutic or Diagnostic Output Failure	8	8
Difficult to Remove	7	7
Extrusion	7	7
Material Protrusion/Extrusion	7	7
Device Contamination with Chemical or Other Material	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	804	1056
Eye Injury	441	449
No Clinical Signs, Symptoms or Conditions	314	323
No Consequences Or Impact To Patient	300	300
No Code Available	286	286
Erosion	253	253
Intraocular Pressure, Delayed, Uncontrolled	231	231
Endophthalmitis	208	210
No Known Impact Or Consequence To Patient	197	197
Intraocular Pressure Decreased	191	199
Hyphema	160	285
Loss of Vision	157	281
Visual Impairment	148	152
Fibrosis	132	132
Hemorrhage/Bleeding	105	105
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	89	93
Corneal Edema	85	85
Inflammation	73	196
Glaucoma	71	71
Retinal Detachment	69	72
No Information	67	67
Failure of Implant	66	66
Macular Edema	65	65
Insufficient Information	64	64
Pain	53	53
Uveitis	50	172
Corneal Decompensation	44	44
Blurred Vision	41	41
Corneal Stromal Edema	38	43
Fluid Discharge	38	38
Therapeutic Response, Decreased	37	37
Intraocular Infection	37	37
Vitreous Hemorrhage	32	32
No Patient Involvement	31	31
Keratitis	29	29
Corneal Touch	25	25
Iritis	25	147
Wound Dehiscence	23	23
Vitrectomy	22	22
Cataract	22	144
Visual Disturbances	19	19
Foreign Body In Patient	18	140
Hyperemia	15	15
Eye Infections	15	15
Scarring	15	15
Adhesion(s)	13	135
Corneal Abrasion	13	13
Eye Pain	12	12
Hypopyon	11	11
Corneal Ulcer	11	11

Recalls
Manufacturer		Recall Class	Date Posted
1	Allergan PLC	II	Dec-04-2019
2	Innovative Ophthalmic Products, Inc	II	Mar-25-2016