TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
5	13	15	8	13	2

MDR Year	MDR Reports	MDR Events
2019	156	156
2020	132	132
2021	157	157
2022	184	184
2023	107	107
2024	21	21

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	452	452
Contamination	120	120
Appropriate Term/Code Not Available	37	37
Device Contaminated During Manufacture or Shipping	22	22
Detachment of Device or Device Component	18	18
Difficult to Remove	16	16
Particulates	15	15
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
Product Quality Problem	4	4
Positioning Problem	4	4
Contamination /Decontamination Problem	4	4
Obstruction of Flow	3	3
Failure to Align	2	2
Patient-Device Incompatibility	2	2
Material Deformation	2	2
Material Separation	2	2
Break	2	2
Physical Resistance/Sticking	2	2
Operating System Becomes Nonfunctional	2	2
Device Handling Problem	1	1
Sharp Edges	1	1
Device Contaminated at the User Facility	1	1
Complete Blockage	1	1
Coagulation in Device or Device Ingredient	1	1
Crack	1	1
Leak/Splash	1	1
Device Emits Odor	1	1
Overheating of Device	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Fungus in Device Environment	1	1
Tear, Rip or Hole in Device Packaging	1	1
Therapy Delivered to Incorrect Body Area	1	1
Precipitate in Device or Device Ingredient	1	1
Material Integrity Problem	1	1
Scratched Material	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Connection Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Human-Device Interface Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Intraocular Pressure Increased	173	173
No Clinical Signs, Symptoms or Conditions	142	142
Toxic Anterior Segment Syndrome (TASS)	101	101
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	90	90
Endophthalmitis	64	64
Corneal Edema	61	61
Inflammation	59	59
No Code Available	51	51
Uveitis	51	51
No Consequences Or Impact To Patient	50	50
Blurred Vision	40	40
Capsular Bag Tear	29	29
No Known Impact Or Consequence To Patient	28	28
Eye Burn	27	27
Visual Impairment	22	22
Hyphema	22	22
Hypopyon	18	18
Pain	18	18
Eye Injury	17	17
Eye Pain	17	17
Conjunctivitis	15	15
Loss of Vision	14	14
No Information	12	12
Foreign Body In Patient	10	10
Intraocular Pressure Decreased	9	9
Vitritis	8	8
Hemorrhage/Bleeding	8	8
Iritis	8	8
Vitrectomy	7	7
Fibrosis	7	7
Nausea	6	6
Vitreous Floaters	5	5
Clouding, Central Corneal	5	5
Rupture	4	4
Visual Disturbances	4	4
No Patient Involvement	4	4
Eye Infections	4	4
Macular Edema	4	4
Keratitis	4	4
Cataract	3	3
Unspecified Infection	3	3
Corneal Clouding/Hazing	3	3
Headache	3	3
Corneal Decompensation	3	3
Corneal Stromal Edema	2	2
Bacterial Infection	2	2
Glaucoma	2	2
Intraocular Infection	2	2
Intraocular Pressure, Delayed, Uncontrolled	2	2
Perforation	2	2
Red Eye(s)	2	2
Retinal Detachment	2	2
Swelling/ Edema	2	2
Zonular Dehiscence	2	2
Vitreous Loss	2	2
Vitreous Hemorrhage	2	2
Vomiting	2	2
Burning Sensation	1	1
Burn, Thermal	1	1
Excessive Tear Production	1	1
Anxiety	1	1
Discomfort	1	1
Injury	1	1
Reaction	1	1
Device Embedded In Tissue or Plaque	1	1
Insufficient Information	1	1
Respiratory Insufficiency	1	1
Occlusion	1	1
Irritation	1	1
Hyperemia	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Capsular Contracture	1	1
Adhesion(s)	1	1
Autoimmune Reaction	1	1

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