TPLC - Total Product Life Cycle

• Device: aid, surgical, viscoelastic
• Product Code: LZP
• Regulation Number: 886.4275
• Device Class: 3

Premarket Approvals (PMA)
2018	2019	2020	2021	2022	2023
8	5	13	15	8	2

MDR Year	MDR Reports	MDR Events
2018	113	113
2019	156	156
2020	132	132
2021	157	157
2022	184	184
2023	37	37

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	453	453
Contamination	96	96
Appropriate Term/Code Not Available	33	33
Detachment of Device or Device Component	24	24
Device Contamination with Chemical or Other Material	23	23
Device Contaminated During Manufacture or Shipping	22	22
Difficult to Remove	18	18
Particulates	14	14
Mechanical Problem	13	13
Leak/Splash	12	12
Contamination /Decontamination Problem	12	12
Disconnection	11	11
Insufficient Information	11	11
Delivered as Unsterile Product	10	10
Manufacturing, Packaging or Shipping Problem	9	9
Separation Problem	7	7
Positioning Problem	4	4
Product Quality Problem	4	4
Break	4	4
Obstruction of Flow	3	3
Failure to Align	2	2
Patient-Device Incompatibility	2	2
Material Separation	2	2
Material Deformation	2	2
Detachment Of Device Component	2	2
Operating System Becomes Nonfunctional	2	2
Device Handling Problem	2	2
Physical Resistance/Sticking	2	2
Sharp Edges	1	1
Packaging Problem	1	1
Human-Device Interface Problem	1	1
Scratched Material	1	1
No Apparent Adverse Event	1	1
Device Contaminated at the User Facility	1	1
Unintended Ejection	1	1
Burst Container or Vessel	1	1
Coagulation in Device or Device Ingredient	1	1
Crack	1	1
Therapy Delivered to Incorrect Body Area	1	1
Precipitate in Device or Device Ingredient	1	1
Occlusion Within Device	1	1
Device Emits Odor	1	1
Overheating of Device	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Connection Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Device Operates Differently Than Expected	1	1
Fungus in Device Environment	1	1
Tear, Rip or Hole in Device Packaging	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	180	180
No Clinical Signs, Symptoms or Conditions	102	102
Toxic Anterior Segment Syndrome (TASS)	98	98
No Consequences Or Impact To Patient	81	81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	76	76
No Code Available	71	71
Inflammation	63	63
Corneal Edema	59	59
Endophthalmitis	55	55
Uveitis	52	52
No Known Impact Or Consequence To Patient	41	41
Blurred Vision	35	35
Eye Burn	26	26
Capsular Bag Tear	26	26
Eye Injury	21	21
Hyphema	21	21
Pain	21	21
Visual Impairment	20	20
Hypopyon	15	15
Loss of Vision	12	12
No Information	12	12
Eye Pain	11	11
Clouding, Central Corneal	11	11
Conjunctivitis	11	11
Vitrectomy	9	9
Foreign Body In Patient	9	9
Vitritis	8	8
Hemorrhage/Bleeding	8	8
Unspecified Infection	7	7
No Patient Involvement	7	7
Intraocular Pressure Decreased	7	7
Nausea	6	6
Corneal Decompensation	6	6
Iritis	5	5
Irritation	5	5
Rupture	5	5
Visual Disturbances	4	4
Vitreous Loss	4	4
Eye Infections	4	4
Headache	4	4
Corneal Clouding/Hazing	3	3
Macular Edema	3	3
Burn, Thermal	3	3
Vitreous Hemorrhage	3	3
Toxicity	3	3
Injury	2	2
Retinal Detachment	2	2
Vomiting	2	2
Fibrosis	2	2
Swelling/ Edema	2	2
Corneal Stromal Edema	2	2
Vitreous Floaters	2	2
Corneal Abrasion	2	2
Intraocular Pressure, Delayed, Uncontrolled	2	2
Keratitis	2	2
Perforation	2	2
Red Eye(s)	1	1
Occlusion	1	1
Intraocular Infection	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Edema	1	1
Adhesion(s)	1	1
Autoimmune Reaction	1	1
Burn(s)	1	1
Capsular Contracture	1	1
Cataract	1	1
Glaucoma	1	1
Insufficient Information	1	1
Blood Loss	1	1
Zonular Dehiscence	1	1
Device Embedded In Tissue or Plaque	1	1
Burning Sensation	1	1
Toxic Shock Syndrome	1	1
Reaction	1	1
Discomfort	1	1

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