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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
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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)
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
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Dislodged or Dislocated
43
43
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
Insufficient Information
3
3
Therapeutic or Diagnostic Output Failure
3
3
Mechanical Problem
3
3
Use of Device Problem
3
3
Unintended Movement
2
2
Defective Device
1
1
Patient Device Interaction Problem
1
1
Positioning Failure
1
1
Pitted
1
1
Device Handling Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Visual Impairment
34
34
No Code Available
30
30
Blurred Vision
16
16
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
Vitreous Detachment
3
3
No Information
3
3
Dry Eye(s)
3
3
Insufficient Information
3
3
Fibrosis
3
3
Vitreous Loss
2
2
Macular Edema
2
2
No Clinical Signs, Symptoms or Conditions
2
2
Glaucoma
2
2
Capsular Contracture
2
2
Loss of Vision
2
2
Headache
2
2
Eye Pain
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Failure of Implant
1
1
Edema
1
1
Retinal Detachment
1
1
Unspecified Eye / Vision Problem
1
1
Pain
1
1
Vitreous Floaters
1
1
Hemorrhage/Bleeding
1
1
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