TPLC - Total Product Life Cycle

• Device: lens, intraocular, accommodative
• Product Code: NAA
• Regulation Number: 886.3600
• Device Class: 3

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
0	0	0	2	0	0

MDR Year	MDR Reports	MDR Events
2019	34	34
2020	23	23
2021	18	18
2022	8	8
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	42	42
Adverse Event Without Identified Device or Use Problem	23	23
Material Twisted/Bent	9	9
Break	8	8
Material Split, Cut or Torn	5	5
Therapeutic or Diagnostic Output Failure	3	3
Insufficient Information	3	3
Mechanical Problem	3	3
Use of Device Problem	3	3
Unintended Movement	2	2
Device Handling Problem	1	1
Patient Device Interaction Problem	1	1
Defective Device	1	1
Pitted	1	1
Positioning Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Visual Impairment	34	34
No Code Available	30	30
Blurred Vision	15	15
Eye Injury	13	13
Halo	9	9
No Known Impact Or Consequence To Patient	7	7
Vitrectomy	6	6
Visual Disturbances	5	5
Capsular Bag Tear	4	4
Fibrosis	3	3
No Information	3	3
Insufficient Information	3	3
Vitreous Detachment	3	3
Dry Eye(s)	3	3
Capsular Contracture	2	2
Macular Edema	2	2
Glaucoma	2	2
Headache	2	2
Vitreous Loss	2	2
Loss of Vision	2	2
Eye Pain	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Unspecified Eye / Vision Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Vitreous Floaters	1	1
Hemorrhage/Bleeding	1	1
Failure of Implant	1	1
Pain	1	1
Retinal Detachment	1	1
Edema	1	1