TPLC - Total Product Life Cycle

• Device: fluid, intraocular
• Product Code: LWL
• Regulation Number: 886.4275
• Device Class: 3

Premarket Approvals (PMA)
2018	2019	2020	2021	2022	2023
1	0	1	3	1	7

MDR Year	MDR Reports	MDR Events
2018	6	6
2019	2	2
2020	7	7
2021	12	12
2022	13	13
2023	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	36	36
Appropriate Term/Code Not Available	7	7
Migration or Expulsion of Device	4	4
Patient-Device Incompatibility	3	3
Air/Gas in Device	2	2
Use of Device Problem	2	2
Break	1	1
Particulates	1	1
Unexpected Therapeutic Results	1	1
Device Contamination with Chemical or Other Material	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	23	23
Retinal Detachment	10	10
Visual Impairment	7	7
Loss of Vision	6	6
Cataract	5	5
Intraocular Pressure Increased	4	4
Hemorrhage/Bleeding	4	4
Blurred Vision	4	4
Inflammation	3	3
Retinal Degeneration	3	3
Intraocular Pressure Decreased	3	3
Hypopyon	3	3
Endophthalmitis	3	3
Pulmonary Edema	2	2
Ischemia	2	2
Toxic Anterior Segment Syndrome (TASS)	2	2
Unspecified Eye / Vision Problem	2	2
Foreign Body In Patient	2	2
Visual Disturbances	2	2
Retinal Tear	2	2
Eye Pain	2	2
Scar Tissue	1	1
Uveitis	1	1
Retinal Injury	1	1
Weakness	1	1
Irritability	1	1
No Known Impact Or Consequence To Patient	1	1
No Code Available	1	1
Laceration(s)	1	1
Myocardial Infarction	1	1
Optical Nerve Damage	1	1
Paralysis	1	1
Red Eye(s)	1	1
Hypoxia	1	1
Eye Injury	1	1
Vitreous Floaters	1	1
Stacking Breaths	1	1
Air Embolism	1	1
Cardiac Arrest	1	1
Chemosis	1	1
Corneal Edema	1	1
Dry Eye(s)	1	1
Macular Edema	1	1
Microcystic Edema	1	1