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	493	493
Contamination	133	135
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	181	181
No Clinical Signs, Symptoms or Conditions	157	159
Toxic Anterior Segment Syndrome (TASS)	115	115
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	101	101
Endophthalmitis	83	83
Corneal Edema	73	73
Inflammation	66	66
Blurred Vision	63	63
Uveitis	56	56
No Code Available	51	51
No Consequences Or Impact To Patient	50	50
Hypopyon	32	32
Eye Burn	29	29
Capsular Bag Tear	29	29
No Known Impact Or Consequence To Patient	28	28
Visual Impairment	23	23
Eye Pain	22	22
Hyphema	22	22
Loss of Vision	20	20
Pain	18	18
Vitritis	18	18
Eye Injury	17	17
Iritis	16	16
Conjunctivitis	15	15
No Information	12	12
Intraocular Pressure Decreased	10	10
Foreign Body In Patient	10	10
Hemorrhage/Bleeding	8	8
Hyperemia	7	7
Fibrosis	7	7
Vitrectomy	7	7
Vitreous Floaters	7	7
Nausea	6	6
Macular Edema	5	5
Insufficient Information	5	5
Clouding, Central Corneal	5	5
Keratitis	5	5
Rupture	5	5
Headache	5	5
No Patient Involvement	4	4
Vitreous Hemorrhage	4	4
Retinal Detachment	4	4
Eye Infections	4	4
Swelling/ Edema	4	4
Visual Disturbances	4	4
Corneal Clouding/Hazing	4	4
Corneal Decompensation	3	3
Cataract	3	3
Unspecified Infection	3	3
Bacterial Infection	2	2

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