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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
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2019
2020
2021
2022
2023
2024
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Device
lens, multifocal intraocular
Product Code
MFK
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
8
4
8
8
6
6
MDR Year
MDR Reports
MDR Events
2019
683
696
2020
912
919
2021
1205
1205
2022
1265
1265
2023
1048
1048
2024
634
678
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3553
3576
Scratched Material
385
386
Appropriate Term/Code Not Available
314
314
Break
244
264
Device Dislodged or Dislocated
181
181
Defective Device
170
170
Patient-Device Incompatibility
143
143
Crack
132
132
Material Opacification
87
87
Malposition of Device
86
86
Device Contamination with Chemical or Other Material
71
71
Therapeutic or Diagnostic Output Failure
50
50
Material Split, Cut or Torn
47
47
Mechanical Problem
35
35
Defective Component
32
32
Failure to Eject
27
27
Unexpected Therapeutic Results
26
26
Failure to Advance
26
26
Device Difficult to Setup or Prepare
25
25
Unintended Movement
25
25
Insufficient Information
22
22
Material Deformation
21
21
Mechanical Jam
19
19
Contamination /Decontamination Problem
19
19
Device Damaged by Another Device
18
18
Positioning Problem
16
16
Material Discolored
15
15
Contamination
14
14
Material Fragmentation
13
13
Power Problem
12
12
Unstable
12
12
Difficult to Fold, Unfold or Collapse
11
11
Application Program Problem: Power Calculation Error
11
11
Ejection Problem
11
11
Failure to Unfold or Unwrap
10
10
Inaccurate Delivery
10
10
Device Markings/Labelling Problem
10
10
Optical Decentration
10
10
Application Program Problem: Dose Calculation Error
9
9
Operating System Becomes Nonfunctional
9
9
Improper or Incorrect Procedure or Method
9
9
Product Quality Problem
8
8
Incorrect, Inadequate or Imprecise Result or Readings
8
8
Failure to Align
8
8
Particulates
7
7
Physical Resistance/Sticking
6
6
Difficult to Advance
6
6
Structural Problem
6
6
Positioning Failure
6
6
Material Twisted/Bent
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
1765
1774
Visual Disturbances
1586
1592
Visual Impairment
1351
1353
Halo
1119
1123
No Clinical Signs, Symptoms or Conditions
563
568
Insufficient Information
500
500
No Code Available
438
438
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
355
355
No Known Impact Or Consequence To Patient
176
176
Dry Eye(s)
131
131
Discomfort
118
118
Failure of Implant
87
87
Headache
81
81
Eye Injury
81
81
Inflammation
78
78
Eye Pain
76
78
Corneal Edema
62
62
Capsular Bag Tear
62
62
No Consequences Or Impact To Patient
61
81
Vitreous Floaters
61
61
Flashers
52
53
Pain
50
50
Therapeutic Effects, Unexpected
46
46
Intraocular Pressure Increased
34
34
Loss of Vision
30
30
Endophthalmitis
30
30
Foreign Body Sensation in Eye
29
29
Red Eye(s)
26
26
Vitrectomy
25
25
Macular Edema
24
24
Unspecified Eye / Vision Problem
23
23
Uveitis
20
20
Dizziness
16
16
Unspecified Infection
14
14
Swelling
14
14
No Patient Involvement
11
11
Inadequate Pain Relief
10
10
Swelling/ Edema
10
10
Fibrosis
9
9
Toxic Anterior Segment Syndrome (TASS)
9
9
Therapeutic Response, Decreased
9
9
Corneal Clouding/Hazing
8
8
Excessive Tear Production
8
8
Zonular Dehiscence
8
8
Iritis
8
8
Conjunctivitis
8
8
No Information
8
8
Nausea
8
8
Increased Sensitivity
7
7
Retinal Tear
7
7
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