TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
5	13	15	8	13	8

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	466	466
Contamination	129	131
Appropriate Term/Code Not Available	38	38
Device Contaminated During Manufacture or Shipping	22	22
Detachment of Device or Device Component	20	20
Difficult to Remove	16	16
Particulates	16	16
Mechanical Problem	14	14
Device Contamination with Chemical or Other Material	13	13
Manufacturing, Packaging or Shipping Problem	11	11
Delivered as Unsterile Product	10	10
Separation Problem	6	6
Positioning Problem	4	4
Contamination /Decontamination Problem	4	4
Product Quality Problem	4	4
Obstruction of Flow	3	3
Operating System Becomes Nonfunctional	2	2
Break	2	2
Physical Resistance/Sticking	2	2
Patient-Device Incompatibility	2	2
Defective Component	2	2
Failure to Align	2	2
Material Deformation	2	2
Material Separation	2	2
Therapy Delivered to Incorrect Body Area	1	1
Device Contaminated at the User Facility	1	1
Overheating of Device	1	1
Human-Device Interface Problem	1	1
Connection Problem	1	1
Fungus in Device Environment	1	1
Coagulation in Device or Device Ingredient	1	1
Device Dislodged or Dislocated	1	1
No Apparent Adverse Event	1	1
Contamination of Device Ingredient or Reagent	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Emits Odor	1	1
Device Handling Problem	1	1
Sharp Edges	1	1
Use of Device Problem	1	1
Precipitate in Device or Device Ingredient	1	1
Scratched Material	1	1
Material Integrity Problem	1	1
Unsealed Device Packaging	1	1
Insufficient Information	1	1
Complete Blockage	1	1
Crack	1	1
Fitting Problem	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	178	178
No Clinical Signs, Symptoms or Conditions	154	156
Toxic Anterior Segment Syndrome (TASS)	107	107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	94	94
Endophthalmitis	65	65
Corneal Edema	63	63
Inflammation	62	62
Uveitis	52	52
No Code Available	51	51
No Consequences Or Impact To Patient	50	50
Blurred Vision	43	43
Capsular Bag Tear	29	29
Eye Burn	29	29
No Known Impact Or Consequence To Patient	28	28
Visual Impairment	22	22
Hyphema	22	22
Hypopyon	20	20
Eye Pain	19	19
Pain	18	18
Loss of Vision	18	18
Eye Injury	17	17
Conjunctivitis	15	15
No Information	12	12
Intraocular Pressure Decreased	10	10
Iritis	10	10
Foreign Body In Patient	10	10
Hemorrhage/Bleeding	8	8
Vitritis	8	8
Fibrosis	7	7
Vitreous Floaters	7	7
Vitrectomy	7	7
Nausea	6	6
Headache	5	5
Keratitis	5	5
Rupture	5	5
Macular Edema	5	5
Clouding, Central Corneal	5	5
Insufficient Information	5	5
Swelling/ Edema	4	4
Visual Disturbances	4	4
Eye Infections	4	4
Vitreous Hemorrhage	4	4
Retinal Detachment	4	4
No Patient Involvement	4	4
Corneal Clouding/Hazing	4	4
Corneal Decompensation	3	3
Cataract	3	3
Unspecified Infection	3	3
Bacterial Infection	2	2
Intraocular Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Johnson & Johnson Surgical Vision Inc	II	Jan-27-2020