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TPLC
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show TPLC since
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2025
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Device
lens, intraocular, phakic
Product Code
MTA
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
1
1
4
0
4
0
MDR Year
MDR Reports
MDR Events
2020
1440
1440
2021
2063
2063
2022
1917
1917
2023
2088
2088
2024
2160
2160
2025
70
70
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inadequacy of Device Shape and/or Size
5047
5047
Off-Label Use
2361
2361
Adverse Event Without Identified Device or Use Problem
2182
2182
No Apparent Adverse Event
1614
1614
Misfocusing
766
766
Optical Problem
256
256
Unintended Movement
177
177
Patient-Device Incompatibility
130
130
Device Dislodged or Dislocated
129
129
Improper or Incorrect Procedure or Method
44
44
Patient Device Interaction Problem
15
15
Appropriate Term/Code Not Available
12
12
Insufficient Information
8
8
Product Quality Problem
5
5
Contamination /Decontamination Problem
4
4
Material Opacification
4
4
Particulates
4
4
Optical Distortion
3
3
Unexpected Color
2
2
Output Problem
2
2
Optical Discoloration
2
2
Scratched Material
2
2
Defective Device
2
2
Ejection Problem
2
2
Mechanical Problem
2
2
Pressure Problem
1
1
Delivered as Unsterile Product
1
1
Inaccurate Information
1
1
Crack
1
1
Difficult to Fold, Unfold or Collapse
1
1
Use of Device Problem
1
1
Material Twisted/Bent
1
1
Contamination
1
1
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
6744
6744
Blurred Vision
857
857
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
736
736
No Code Available
662
662
Intraocular Pressure Increased
428
428
Visual Disturbances
296
296
Halo
262
262
Cataract
217
217
Toxic Anterior Segment Syndrome (TASS)
136
136
No Known Impact Or Consequence To Patient
91
91
No Consequences Or Impact To Patient
87
87
Inflammation
72
72
Headache
53
53
Discomfort
50
50
Corneal Edema
46
46
Pupillary Block
41
41
Endophthalmitis
33
33
Pain
30
30
Eye Pain
27
27
Glaucoma
23
23
Retinal Detachment
23
23
Dry Eye(s)
20
20
Uveitis
18
18
Iritis
17
17
No Patient Involvement
17
17
Corneal Decompensation
12
12
Insufficient Information
9
9
Foreign Body Sensation in Eye
8
8
Hyphema
6
6
Red Eye(s)
6
6
Fatigue
5
5
Cyst(s)
4
4
Dizziness
4
4
Visual Impairment
4
4
Eye Injury
3
3
Vitreous Floaters
3
3
Loss of Vision
3
3
Capsular Bag Tear
3
3
Excessive Tear Production
2
2
Flashers
2
2
Itching Sensation
2
2
Swelling/ Edema
2
2
Corneal Touch
2
2
Nausea
2
2
Failure of Implant
1
1
Deposits
1
1
Hypopyon
1
1
Optical Nerve Damage
1
1
Increased Sensitivity
1
1
Corneal Abrasion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Staar Surgical Company
II
Dec-01-2023
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