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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
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2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
lens, intraocular, accommodative
Product Code
NAA
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
2
0
0
MDR Year
MDR Reports
MDR Events
2017
68
68
2018
49
49
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
121
121
Adverse Event Without Identified Device or Use Problem
50
50
Break
12
12
Material Twisted/Bent
11
11
Insufficient Information
5
5
Material Split, Cut or Torn
5
5
Mechanical Problem
3
3
Use of Device Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Unintended Movement
3
3
Difficult To Position
2
2
Torn Material
1
1
Defective Device
1
1
Difficult to Advance
1
1
Optical Discoloration
1
1
Material Opacification
1
1
Pitted
1
1
Positioning Failure
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Visual Impairment
91
91
No Known Impact Or Consequence To Patient
37
37
No Code Available
31
31
Blurred Vision
29
29
Visual Disturbances
16
16
Capsular Bag Tear
13
13
Eye Injury
13
13
Halo
10
10
Vitrectomy
9
9
Fibrosis
8
8
Pain
7
7
Capsular Contracture
4
4
Dry Eye(s)
4
4
No Information
4
4
Loss of Vision
3
3
Glaucoma
3
3
Macular Edema
3
3
Insufficient Information
3
3
Vitreous Detachment
3
3
Vitreous Loss
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Eye Pain
2
2
Corneal Edema
2
2
Retinal Detachment
2
2
Zonular Dehiscence
2
2
Discomfort
2
2
Headache
2
2
Keratitis
1
1
Irritation
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Endophthalmitis
1
1
Uveitis
1
1
Edema
1
1
Hemorrhage/Bleeding
1
1
Inflammation
1
1
Vitreous Floaters
1
1
Hypopyon
1
1
Post Operative Wound Infection
1
1
Unspecified Eye / Vision Problem
1
1
Failure of Implant
1
1
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