TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
1	3	1	11	2	0

MDR Year	MDR Reports	MDR Events
2020	7	7
2021	12	12
2022	13	13
2023	18	18
2024	16	16
2025	20	20

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	61	61
Appropriate Term/Code Not Available	8	8
Patient-Device Incompatibility	5	5
Migration or Expulsion of Device	3	3
Air/Gas in Device	2	2
Break	1	1
Off-Label Use	1	1
Use of Device Problem	1	1
Particulates	1	1
Packaging Problem	1	1
Product Quality Problem	1	1
Material Protrusion/Extrusion	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
Visual Impairment	17	17
Blurred Vision	13	13
Retinal Detachment	13	13
Loss of Vision	10	10
Cataract	7	7
Intraocular Pressure Increased	6	6
Toxic Anterior Segment Syndrome (TASS)	6	6
Retinal Degeneration	5	5
Inflammation	5	5
Hemorrhage/Bleeding	4	4
Intraocular Pressure Decreased	4	4
Retinal Tear	3	3
Hypopyon	3	3
Vitreous Hemorrhage	3	3
Endophthalmitis	3	3
Unspecified Eye / Vision Problem	3	3
Uveitis	2	2
Eye Pain	2	2
Pulmonary Edema	2	2
Visual Disturbances	2	2
Dry Eye(s)	2	2
Ischemia	2	2
Macular Edema	2	2
Vitreous Detachment	2	2
Eye Burn	1	1
Cardiac Arrest	1	1
Retinal Injury	1	1
Foreign Body Reaction	1	1
Capsular Bag Tear	1	1
Optical Nerve Damage	1	1
Microcystic Edema	1	1
Laceration(s)	1	1
Dizziness	1	1
Scar Tissue	1	1
Eye Injury	1	1
Failure of Implant	1	1
Chemosis	1	1
Corneal Edema	1	1
Vitreous Floaters	1	1
Red Eye(s)	1	1
Hypoxia	1	1
Pupillary Block	1	1
Hypersensitivity/Allergic reaction	1	1
Stacking Breaths	1	1
Irritability	1	1
Foreign Body Sensation in Eye	1	1
Infiltration into Tissue	1	1
Headache	1	1
Corneal Scar	1	1