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TPLC
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show TPLC since
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2024
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Device
lens, guide, intraocular
Product Code
KYB
Regulation Number
886.4300
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
703
757
2020
335
408
2021
349
369
2022
294
294
2023
304
304
2024
95
95
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
257
274
Device Damaged by Another Device
255
289
Failure to Eject
245
245
Crack
196
302
Scratched Material
168
168
Defective Device
139
139
Contamination
121
121
Failure to Advance
102
102
Physical Resistance/Sticking
96
96
Defective Component
68
68
Material Twisted/Bent
65
65
Activation, Positioning or Separation Problem
64
64
Material Split, Cut or Torn
59
59
Adverse Event Without Identified Device or Use Problem
50
50
Mechanical Jam
45
45
Inaccurate Delivery
45
45
Appropriate Term/Code Not Available
43
43
Difficult to Advance
41
41
Device Contamination with Chemical or Other Material
40
40
Unintended Ejection
40
40
Failure to Unfold or Unwrap
34
34
Positioning Problem
29
29
Mechanical Problem
25
25
Material Deformation
24
24
Failure to Deliver
21
21
Material Fragmentation
19
19
Therapeutic or Diagnostic Output Failure
19
19
Entrapment of Device
18
18
Device Difficult to Setup or Prepare
16
16
Material Integrity Problem
15
15
Malposition of Device
14
14
Failure to Fold
13
13
Contamination /Decontamination Problem
13
13
Device Dislodged or Dislocated
12
12
Difficult to Fold, Unfold or Collapse
12
12
Difficult to Insert
11
11
Premature Activation
10
10
Delivered as Unsterile Product
9
9
Use of Device Problem
9
9
Unintended Movement
9
9
Manufacturing, Packaging or Shipping Problem
8
8
Detachment of Device or Device Component
8
8
Material Too Rigid or Stiff
7
7
Positioning Failure
6
6
Deformation Due to Compressive Stress
6
6
Failure to Align
5
5
Misfire
5
5
Material Opacification
5
5
Device Contaminated During Manufacture or Shipping
5
5
Ejection Problem
5
5
Firing Problem
5
5
Output Problem
4
4
Device Markings/Labelling Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Device Damaged Prior to Use
4
4
Material Separation
4
4
Component Missing
4
4
Device Slipped
3
3
Stretched
3
3
Material Discolored
3
3
Activation Problem
3
3
No Apparent Adverse Event
3
3
Insufficient Information
2
2
Pressure Problem
2
2
Sharp Edges
2
2
Mechanics Altered
2
2
Difficult to Open or Close
2
2
Output above Specifications
2
2
Migration or Expulsion of Device
2
2
Material Rupture
2
2
Product Quality Problem
2
2
Difficult to Remove
2
2
Loose or Intermittent Connection
2
2
Particulates
2
2
Structural Problem
2
2
Device Displays Incorrect Message
2
2
Failure to Fire
1
1
Device Tipped Over
1
1
Separation Failure
1
1
Dent in Material
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Patient-Device Incompatibility
1
1
Failure to Infuse
1
1
Tear, Rip or Hole in Device Packaging
1
1
Obstruction of Flow
1
1
Unstable
1
1
Inadequacy of Device Shape and/or Size
1
1
Peeled/Delaminated
1
1
Self-Activation or Keying
1
1
Misassembled
1
1
Material Frayed
1
1
Image Orientation Incorrect
1
1
Unsealed Device Packaging
1
1
Unintended Collision
1
1
Material Disintegration
1
1
Difficult or Delayed Positioning
1
1
Corroded
1
1
Complete Blockage
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Invagination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
675
685
No Known Impact Or Consequence To Patient
527
548
Insufficient Information
329
342
No Consequences Or Impact To Patient
252
365
Capsular Bag Tear
58
58
No Code Available
44
44
No Patient Involvement
41
41
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
38
38
Failure of Implant
28
28
Corneal Edema
23
23
Eye Injury
22
22
Blurred Vision
14
14
Visual Disturbances
12
12
Eye Pain
11
11
Rupture
10
11
Inflammation
10
10
Visual Impairment
9
9
Tissue Damage
9
9
Endophthalmitis
8
8
Foreign Body In Patient
8
8
Discomfort
5
5
No Information
5
5
Hemorrhage/Bleeding
5
5
Intraocular Pressure Increased
5
5
Uveitis
4
4
Fibrosis
4
4
Prolapse
4
4
Zonular Dehiscence
3
3
Device Embedded In Tissue or Plaque
3
3
Hypopyon
3
3
Unspecified Infection
3
3
Hyperemia
2
2
Hyphema
2
2
Conjunctivitis
2
2
Vitreous Floaters
2
2
Patient Problem/Medical Problem
2
2
Injury
2
2
Blood Loss
2
2
Toxic Anterior Segment Syndrome (TASS)
1
1
Swelling/ Edema
1
1
Collapse
1
1
Vitreous Detachment
1
1
Organ Dehiscence
1
1
Vitreous Hemorrhage
1
1
Vomiting
1
1
Intraoperative Pain
1
1
Vitrectomy
1
1
Glaucoma
1
1
Corneal Clouding/Hazing
1
1
Headache
1
1
Corneal Perforation
1
1
Dry Eye(s)
1
1
Macular Edema
1
1
Corneal Abrasion
1
1
Loss of Vision
1
1
Halo
1
1
Viral Infection
1
1
Nausea
1
1
Pain
1
1
Red Eye(s)
1
1
Retinal Detachment
1
1
Retinal Tear
1
1
Scar Tissue
1
1
Swelling
1
1
Therapeutic Effects, Unexpected
1
1
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