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TPLC
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show TPLC since
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Device
intraocular lens
Product Code
HQL
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
39
57
49
54
34
9
MDR Year
MDR Reports
MDR Events
2018
2501
2501
2019
3086
3603
2020
1982
3097
2021
2929
3100
2022
3300
3300
2023
1506
1554
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3440
3488
Break
3022
4458
Scratched Material
1136
1200
Crack
785
927
Defective Device
543
543
Material Split, Cut or Torn
486
486
Appropriate Term/Code Not Available
422
422
Failure to Eject
410
410
Contamination
400
400
Material Opacification
382
382
Device Contamination with Chemical or Other Material
350
350
Inaccurate Delivery
345
345
Device Dislodged or Dislocated
322
322
Material Fragmentation
300
300
Failure to Advance
255
255
Unintended Movement
241
241
Use of Device Problem
224
224
No Apparent Adverse Event
217
217
Physical Resistance/Sticking
204
204
Failure to Unfold or Unwrap
200
200
Material Twisted/Bent
185
185
Difficult to Fold, Unfold or Collapse
181
181
Mechanical Jam
180
180
Contamination /Decontamination Problem
164
164
Insufficient Information
159
159
Defective Component
156
271
Device Damaged by Another Device
138
184
Off-Label Use
134
134
Failure to Fold
125
125
Device Operates Differently Than Expected
118
118
Material Deformation
117
117
Difficult to Advance
97
97
Inadequacy of Device Shape and/or Size
96
96
Mechanical Problem
89
89
Device Contaminated During Manufacture or Shipping
84
84
Malposition of Device
83
83
Positioning Problem
79
79
Material Integrity Problem
77
77
Patient-Device Incompatibility
75
75
Optical Problem
73
73
Separation Problem
67
67
Device Handling Problem
66
66
Difficult to Insert
65
65
Device Difficult to Setup or Prepare
65
65
Positioning Failure
63
63
Calcified
62
62
Product Quality Problem
61
61
Premature Activation
58
58
Delivered as Unsterile Product
56
56
Improper or Incorrect Procedure or Method
54
54
Material Too Rigid or Stiff
54
54
Difficult or Delayed Positioning
53
53
Material Discolored
48
48
Operating System Becomes Nonfunctional
48
48
Detachment of Device or Device Component
46
46
Unintended Ejection
46
46
Ejection Problem
46
46
Unstable
45
45
Torn Material
41
41
Activation, Positioning or Separation Problem
39
39
Manufacturing, Packaging or Shipping Problem
38
38
Device Markings/Labelling Problem
37
37
Fracture
37
37
Unexpected Therapeutic Results
35
35
Sharp Edges
35
35
Device Appears to Trigger Rejection
30
30
Sticking
27
27
Device Damaged Prior to Use
26
26
Material Rupture
25
25
Entrapment of Device
25
25
Optical Distortion
23
23
Split
22
22
Structural Problem
20
20
Deformation Due to Compressive Stress
20
20
Therapeutic or Diagnostic Output Failure
20
43
Detachment Of Device Component
20
20
Failure to Align
19
19
Bent
18
18
Failure to Deliver
15
15
Material Separation
14
14
Incorrect, Inadequate or Imprecise Result or Readings
14
14
Migration or Expulsion of Device
13
13
Component Missing
12
12
Packaging Problem
12
12
Inaccurate Information
12
12
Dent in Material
11
11
Contamination of Device Ingredient or Reagent
10
10
Patient Device Interaction Problem
10
10
Activation Problem
9
9
Material Frayed
9
9
Particulates
9
9
Misfocusing
8
8
Optical Decentration
8
8
Application Program Problem: Dose Calculation Error
7
7
Output Problem
7
7
Device Fell
7
7
Protective Measures Problem
6
6
Hole In Material
6
6
Device Slipped
6
6
Loose or Intermittent Connection
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4115
4145
No Code Available
2099
2099
No Known Impact Or Consequence To Patient
1804
1989
No Consequences Or Impact To Patient
1251
2823
Visual Impairment
1201
1201
Insufficient Information
1142
1175
Blurred Vision
867
868
Capsular Bag Tear
830
830
Visual Disturbances
741
741
No Patient Involvement
591
591
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
573
621
Vitrectomy
428
428
Halo
263
263
Eye Injury
261
261
Failure of Implant
236
236
Inflammation
211
211
Corneal Edema
197
197
Endophthalmitis
140
140
No Information
107
107
Intraocular Pressure Increased
98
146
Discomfort
91
91
Toxic Anterior Segment Syndrome (TASS)
69
69
Therapeutic Effects, Unexpected
66
66
Pain
66
66
Dry Eye(s)
60
60
Eye Pain
59
59
Uveitis
57
105
Macular Edema
50
98
Zonular Dehiscence
48
48
Loss of Vision
45
45
Vitreous Loss
44
44
Red Eye(s)
43
43
Vitreous Floaters
39
39
Rupture
39
39
Hemorrhage/Bleeding
37
37
Flashers
37
37
Retinal Detachment
34
82
Unspecified Infection
33
33
Foreign Body In Patient
33
33
Iritis
28
28
Foreign Body Sensation in Eye
28
28
Glaucoma
26
26
Corneal Clouding/Hazing
24
24
Hyphema
24
24
Hypopyon
20
20
Edema
20
20
Fibrosis
20
20
Headache
18
18
Vitreous Hemorrhage
17
17
Irritation
14
14
Nausea
14
14
Intraocular Infection
13
13
Deposits
13
13
Capsular Contracture
13
13
Complaint, Ill-Defined
13
13
Patient Problem/Medical Problem
13
13
Tissue Damage
12
12
Swelling
12
13
Hyperemia
11
11
Calcium Deposits/Calcification
11
11
Excessive Tear Production
11
11
Swelling/ Edema
11
11
Dizziness
10
10
Vitreous Detachment
9
9
Prolapse
9
9
Unspecified Eye / Vision Problem
9
9
Therapeutic Response, Decreased
8
8
Erythema
8
8
Bacterial Infection
8
8
Eye Infections
8
8
Conjunctivitis
7
7
Retinal Tear
7
7
Reaction
7
7
Burning Sensation
7
7
Intraocular Pressure Decreased
7
7
UGH (Uveitis Glaucoma Hyphema) Syndrome
6
6
UGH (Uveitis-Glaucoma-Hyphema) Syndrome
6
6
Increased Sensitivity
6
6
Keratitis
6
6
High Blood Pressure/ Hypertension
6
6
Corneal Abrasion
6
6
Corneal Decompensation
6
6
Adhesion(s)
6
54
Wound Dehiscence
5
5
Cataract
5
5
Hypersensitivity/Allergic reaction
5
5
Scarring
5
5
Injury
5
5
Impaired Healing
5
5
Inadequate Pain Relief
4
4
Disability
4
4
Discharge
4
4
Itching Sensation
4
4
Corneal Stromal Edema
4
4
Fever
4
4
Retinal Injury
3
3
Vitritis
3
3
Collapse
3
3
Anxiety
3
3
Blood Loss
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Alcon Laboratories Ireland, Ltd
II
Jun-17-2022
2
Alcon Research LLC
II
Jun-05-2020
3
Bausch & Lomb Surgical, Inc.
II
Jul-10-2020
4
Bausch & Lomb Surgical, Inc.
II
Dec-18-2018
5
Johnson & Johnson Surgical Vision Inc
II
Nov-14-2018
6
Rayner Intraocular Lenses Limited
II
Sep-28-2018
7
Rayner Intraocular Lenses Ltd
II
Jul-06-2022
8
Tekia, Inc.
II
Dec-17-2019
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