Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
0
MDR Year
MDR Reports
MDR Events
2019
683
696
2020
912
919
2021
1205
1205
2022
1265
1265
2023
1048
1048
2024
254
254
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3294
3294
Scratched Material
349
349
Appropriate Term/Code Not Available
309
309
Break
224
244
Device Dislodged or Dislocated
166
166
Defective Device
160
160
Patient-Device Incompatibility
143
143
Crack
122
122
Malposition of Device
82
82
Material Opacification
80
80
Device Contamination with Chemical or Other Material
71
71
Therapeutic or Diagnostic Output Failure
50
50
Material Split, Cut or Torn
44
44
Mechanical Problem
35
35
Defective Component
30
30
Unexpected Therapeutic Results
26
26
Failure to Advance
26
26
Unintended Movement
25
25
Insufficient Information
21
21
Failure to Eject
20
20
Contamination /Decontamination Problem
19
19
Device Difficult to Setup or Prepare
19
19
Mechanical Jam
17
17
Positioning Problem
16
16
Device Damaged by Another Device
16
16
Material Deformation
12
12
Power Problem
12
12
Contamination
11
11
Material Discolored
11
11
Material Fragmentation
10
10
Application Program Problem: Power Calculation Error
10
10
Device Markings/Labelling Problem
10
10
Unstable
10
10
Inaccurate Delivery
10
10
Improper or Incorrect Procedure or Method
9
9
Failure to Unfold or Unwrap
9
9
Difficult to Fold, Unfold or Collapse
9
9
Application Program Problem: Dose Calculation Error
9
9
Product Quality Problem
8
8
Failure to Align
8
8
Operating System Becomes Nonfunctional
8
8
Ejection Problem
8
8
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Structural Problem
6
6
Difficult to Advance
6
6
Particulates
6
6
Optical Decentration
6
6
Positioning Failure
6
6
Physical Resistance/Sticking
6
6
Activation, Positioning or Separation Problem
5
5
Material Too Rigid or Stiff
5
5
Use of Device Problem
4
4
Dent in Material
4
4
Failure to Fold
4
4
Material Twisted/Bent
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Optical Problem
3
3
Patient Device Interaction Problem
3
3
Fracture
3
3
Material Frayed
3
3
Difficult to Insert
3
3
Labelling, Instructions for Use or Training Problem
3
3
Entrapment of Device
3
3
Incorrect Measurement
3
3
Delivered as Unsterile Product
3
3
Device Displays Incorrect Message
3
3
Detachment of Device or Device Component
3
3
Material Rupture
3
3
Device Damaged Prior to Use
3
3
Component Missing
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Material Integrity Problem
2
2
Loose or Intermittent Connection
2
2
Migration or Expulsion of Device
2
2
Unintended Ejection
2
2
Fogging
2
2
Calcified
2
2
Output Problem
2
2
Optical Distortion
1
1
Mechanics Altered
1
1
Material Too Soft/Flexible
1
1
Sharp Edges
1
1
Activation Problem
1
1
Separation Problem
1
1
Biofilm coating in Device
1
1
Leak/Splash
1
1
Image Orientation Incorrect
1
1
Degraded
1
1
Misassembled
1
1
Misfocusing
1
1
Unable to Obtain Readings
1
1
Difficult to Remove
1
1
Material Puncture/Hole
1
1
Compatibility Problem
1
1
Difficult to Open or Close
1
1
Deformation Due to Compressive Stress
1
1
Stretched
1
1
Fitting Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
1628
1628
Visual Disturbances
1473
1473
Visual Impairment
1277
1277
Halo
1065
1065
No Clinical Signs, Symptoms or Conditions
509
509
No Code Available
438
438
Insufficient Information
433
433
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
345
345
No Known Impact Or Consequence To Patient
176
176
Dry Eye(s)
125
125
Discomfort
108
108
Failure of Implant
85
85
Headache
77
77
Inflammation
76
76
Eye Injury
69
69
Eye Pain
67
67
No Consequences Or Impact To Patient
61
81
Corneal Edema
58
58
Vitreous Floaters
57
57
Capsular Bag Tear
53
53
Flashers
50
50
Pain
50
50
Therapeutic Effects, Unexpected
46
46
Intraocular Pressure Increased
31
31
Loss of Vision
30
30
Endophthalmitis
30
30
Foreign Body Sensation in Eye
29
29
Red Eye(s)
26
26
Vitrectomy
25
25
Unspecified Eye / Vision Problem
23
23
Macular Edema
21
21
Uveitis
18
18
Dizziness
15
15
Swelling
14
14
Unspecified Infection
14
14
No Patient Involvement
11
11
Inadequate Pain Relief
10
10
Swelling/ Edema
10
10
Toxic Anterior Segment Syndrome (TASS)
9
9
Therapeutic Response, Decreased
9
9
Zonular Dehiscence
8
8
Fibrosis
8
8
No Information
8
8
Corneal Clouding/Hazing
8
8
Conjunctivitis
8
8
Iritis
8
8
Nausea
8
8
Increased Sensitivity
7
7
Burning Sensation
7
7
Corneal Scar
7
7
Hypopyon
7
7
Foreign Body In Patient
7
7
Anxiety
7
7
Excessive Tear Production
7
7
Irritability
7
7
Patient Problem/Medical Problem
6
6
Hemorrhage/Bleeding
6
6
Fatigue
6
6
Emotional Changes
6
6
Vertigo
6
6
Itching Sensation
6
6
Retinal Detachment
6
6
Retinal Tear
5
5
Scar Tissue
5
5
Keratitis
5
5
Vitreous Loss
5
5
Corneal Abrasion
5
5
Vitreous Detachment
5
5
Complaint, Ill-Defined
5
5
Injury
4
4
Depression
4
4
Prolapse
4
4
Decreased Sensitivity
4
4
Increased Sensitivity
4
4
Capsular Contracture
4
4
Cataract
4
4
Hypersensitivity/Allergic reaction
4
4
Hyphema
4
4
Hyperemia
3
3
Cataract, Induced
3
3
Fall
3
3
Scarring
3
3
Clouding, Central Corneal
3
3
Distress
2
2
Impaired Healing
2
2
Confusion/ Disorientation
2
2
Unspecified Tissue Injury
2
2
UGH (Uveitis Glaucoma Hyphema) Syndrome
2
2
Corneal Epithelial Microcysts
2
2
Staphylococcus Aureus
2
2
Nerve Damage
2
2
Vitreous Hemorrhage
2
2
Twitching
2
2
Vitritis
2
2
Retinal Degeneration
2
2
Tissue Damage
2
2
Edema
2
2
Purulent Discharge
2
2
Chemosis
1
1
Erythema
1
1
-
-