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TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
lens, intraocular, phakic
Product Code
MTA
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
3
5
4
2
1
2
2
0
5
3
6
1
1
4
0
2
MDR Year
MDR Reports
MDR Events
2014
781
781
2015
1279
1279
2016
1456
1456
2017
1796
1796
2018
1778
1778
2019
1236
1236
2020
1440
1440
2021
2063
2063
2022
1917
1917
2023
2088
2088
2024
1477
1477
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequacy of Device Shape and/or Size
10206
10206
Off-Label Use
2574
2574
Appropriate Term/Code Not Available
2465
2465
Adverse Event Without Identified Device or Use Problem
1939
1939
No Apparent Adverse Event
1719
1719
Device Operates Differently Than Expected
1107
1107
Misfocusing
993
993
Device Dislodged or Dislocated
474
474
Unintended Movement
407
407
Optical Problem
342
342
Torn Material
252
252
Insufficient Information
234
234
Patient-Device Incompatibility
167
167
Break
87
87
Improper or Incorrect Procedure or Method
68
68
Positioning Failure
51
51
Device Contamination with Chemical or Other Material
25
25
Material Opacification
15
15
Patient Device Interaction Problem
15
15
Difficult to Fold, Unfold or Collapse
15
15
Activation Failure
13
13
Contamination /Decontamination Problem
11
11
Use of Device Problem
9
9
Scratched Material
9
9
Failure to Unfold or Unwrap
8
8
Defective Device
8
8
Positioning Problem
8
8
Device Markings/Labelling Problem
6
6
Entrapment of Device
5
5
Product Quality Problem
5
5
Difficult to Insert
5
5
Ejection Problem
5
5
Crack
5
5
Missing Value Reason
4
4
Sticking
4
4
Difficult To Position
4
4
Bent
4
4
Contamination
4
4
Inaccurate Information
4
4
Fracture
4
4
Malposition of Device
4
4
Optical Decentration
3
3
Mechanical Jam
3
3
Particulates
3
3
Optical Distortion
3
3
Device Slipped
3
3
Activation, Positioning or Separation Problem
3
3
Failure to Select Signal
2
2
Incomplete or Missing Packaging
2
2
Output Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
7167
7167
No Clinical Signs, Symptoms or Conditions
6259
6259
Blurred Vision
1574
1574
Intraocular Pressure Increased
1117
1117
No Known Impact Or Consequence To Patient
927
927
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
667
667
Halo
557
557
Visual Disturbances
550
550
Cataract
508
508
No Consequences Or Impact To Patient
475
475
No Information
258
258
Cataract, Induced
200
200
Pupillary Block
161
161
No Patient Involvement
140
140
Inflammation
130
130
Pain
129
129
Headache
118
118
Corneal Edema
116
116
Loss of Vision
112
112
Discomfort
106
106
Toxic Anterior Segment Syndrome (TASS)
90
90
Endophthalmitis
69
69
Glaucoma
65
65
Visual Impairment
59
59
Iritis
42
42
Uveitis
37
37
Dry Eye(s)
36
36
Retinal Detachment
34
34
Intraocular Pressure, Delayed, Uncontrolled
28
28
Eye Pain
25
25
Corneal Decompensation
24
24
Nausea
13
13
Red Eye(s)
12
12
Vitrectomy
12
12
Foreign Body Sensation in Eye
12
12
Hyphema
11
11
Cyst(s)
10
10
Vomiting
10
10
Vitreous Floaters
9
9
Insufficient Information
9
9
Capsular Bag Tear
8
8
Dizziness
7
7
Patient Problem/Medical Problem
7
7
Edema
6
6
Not Applicable
6
6
Hypopyon
5
5
Fatigue
5
5
Swelling
5
5
Missing Value Reason
5
5
Macular Edema
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Staar Surgical Company
II
Dec-01-2023
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