TPLC - Total Product Life Cycle

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Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
13	15	8	13	10	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	439	440
Contamination	110	120
Appropriate Term/Code Not Available	29	29
Device Contaminated During Manufacture or Shipping	22	22
Detachment of Device or Device Component	18	18
Particulates	17	17
Manufacturing, Packaging or Shipping Problem	14	14
Mechanical Problem	13	15
Delivered as Unsterile Product	12	12
Device Contamination with Chemical or Other Material	12	12
Difficult to Remove	7	7
Positioning Problem	4	4
Fitting Problem	3	3
Obstruction of Flow	3	3
Product Quality Problem	3	3
Operating System Becomes Nonfunctional	2	2
Break	2	2
Physical Resistance/Sticking	2	2
Defective Component	2	2
Use of Device Problem	2	3
Failure to Align	2	2
Material Separation	2	2
Leak/Splash	1	1
Separation Problem	1	1
Crack	1	1
Complete Blockage	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Expiration Date Error	1	2
Material Integrity Problem	1	1
Contamination /Decontamination Problem	1	1
Air/Gas in Device	1	1
Precipitate in Device or Device Ingredient	1	1
Sharp Edges	1	1
Material Deformation	1	1
No Apparent Adverse Event	1	1
Device Dislodged or Dislocated	1	1
Coagulation in Device or Device Ingredient	1	1
Connection Problem	1	1
Device Contaminated at the User Facility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	171	183
Intraocular Pressure Increased	128	128
Toxic Anterior Segment Syndrome (TASS)	118	118
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	102	102
Endophthalmitis	79	79
Inflammation	66	66
Corneal Edema	65	65
Blurred Vision	62	62
Uveitis	59	59
No Consequences Or Impact To Patient	34	34
Hypopyon	33	33
Eye Burn	30	30
Eye Pain	23	23
No Code Available	23	23
Hyphema	23	24
Capsular Bag Tear	22	22
Loss of Vision	20	20
Visual Impairment	20	20
Eye Injury	19	20
Vitritis	18	18
Conjunctivitis	14	14
Iritis	12	12
No Information	12	12
Intraocular Pressure Decreased	11	11
Vitreous Floaters	9	9
Hyperemia	7	7
Fibrosis	7	7
Insufficient Information	7	7
No Known Impact Or Consequence To Patient	7	7
Headache	6	6
Pain	6	6
Foreign Body In Patient	6	6
Corneal Clouding/Hazing	6	6
Vitrectomy	5	5
Clouding, Central Corneal	5	5
Keratitis	5	5
Hemorrhage/Bleeding	5	5
Macular Edema	5	5
Retinal Detachment	4	4
Swelling/ Edema	4	4
Vitreous Hemorrhage	4	4
Eye Infections	4	4
Zonular Dehiscence	3	3
Visual Disturbances	3	3
Rupture	3	3
Cataract	3	3
Excessive Tear Production	2	2
Retinal Tear	2	2
Unspecified Infection	2	2
Corneal Perforation	2	3

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