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TPLC
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Device
extended depth of focus intraocular lens
Definition
Intended to be implanted to replace the natural lens of an eye.
Product Code
POE
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
0
3
1
6
3
0
MDR Year
MDR Reports
MDR Events
2019
735
819
2020
347
358
2021
598
599
2022
635
635
2023
552
552
2024
197
197
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2107
2107
Scratched Material
187
187
Device Dislodged or Dislocated
105
105
Break
94
190
Appropriate Term/Code Not Available
87
87
Defective Device
82
82
Unintended Movement
69
69
Crack
53
53
Device Contamination with Chemical or Other Material
38
38
Malposition of Device
36
36
Unstable
30
30
Material Opacification
25
25
Insufficient Information
18
18
Material Split, Cut or Torn
17
17
Mechanical Problem
16
16
Defective Component
15
15
Contamination
13
13
Device Damaged by Another Device
13
13
Failure to Eject
12
12
Use of Device Problem
12
12
Failure to Advance
12
12
Application Program Problem: Power Calculation Error
11
11
Optical Decentration
9
9
Material Fragmentation
8
8
Product Quality Problem
8
8
Inaccurate Delivery
8
8
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Failure to Unfold or Unwrap
7
7
Patient-Device Incompatibility
7
7
Contamination /Decontamination Problem
6
6
Application Program Problem: Dose Calculation Error
6
6
Difficult to Fold, Unfold or Collapse
6
6
Inadequacy of Device Shape and/or Size
5
5
Unexpected Therapeutic Results
5
5
Structural Problem
5
5
Failure to Align
4
4
Material Discolored
4
4
Device Markings/Labelling Problem
4
4
Material Twisted/Bent
3
3
Positioning Problem
3
3
No Apparent Adverse Event
3
3
Difficult to Insert
3
3
Labelling, Instructions for Use or Training Problem
3
3
Nonstandard Device
3
3
Delivered as Unsterile Product
3
3
Dent in Material
3
3
Device Difficult to Setup or Prepare
3
3
Failure to Fold
2
2
Positioning Failure
2
2
Patient Device Interaction Problem
2
2
Physical Resistance/Sticking
2
2
Ejection Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Particulates
2
2
Difficult to Advance
2
2
Detachment of Device or Device Component
2
2
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Mechanical Jam
1
1
Packaging Problem
1
1
Air/Gas in Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Fracture
1
1
Unsealed Device Packaging
1
1
Device Damaged Prior to Use
1
1
Failure to Deliver
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
952
952
No Code Available
881
881
Visual Disturbances
768
768
Visual Impairment
669
669
Halo
518
518
No Clinical Signs, Symptoms or Conditions
302
302
Insufficient Information
261
261
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
196
196
Dry Eye(s)
90
90
Flashers
53
53
Corneal Edema
51
51
Discomfort
51
51
Headache
47
47
Capsular Bag Tear
45
45
Inflammation
39
39
Eye Injury
39
39
Eye Pain
38
38
Therapeutic Effects, Unexpected
36
36
No Consequences Or Impact To Patient
31
127
Vitrectomy
31
31
Vitreous Floaters
25
25
Macular Edema
21
21
Intraocular Pressure Increased
19
19
Nausea
15
15
Pain
15
15
Dizziness
15
15
Foreign Body Sensation in Eye
14
14
No Known Impact Or Consequence To Patient
13
13
No Patient Involvement
11
11
Excessive Tear Production
10
10
Endophthalmitis
10
10
Unspecified Eye / Vision Problem
10
10
Uveitis
8
8
Zonular Dehiscence
7
7
Conjunctivitis
7
7
Red Eye(s)
6
6
Irritation
6
6
Itching Sensation
6
6
Irritability
6
6
Swelling/ Edema
6
6
Unspecified Infection
5
5
Iritis
5
5
Glaucoma
5
5
Failure of Implant
4
4
Hypersensitivity/Allergic reaction
3
3
Corneal Clouding/Hazing
3
3
Corneal Abrasion
3
3
Swelling
3
3
Fibrosis
3
3
Intraocular Pressure Decreased
3
3
Toxic Anterior Segment Syndrome (TASS)
3
3
Unspecified Tissue Injury
3
3
Balance Problems
2
2
Ptosis
2
2
Vitreous Loss
2
2
Rupture
2
2
Capsular Contracture
2
2
Corneal Scar
2
2
Fatigue
2
2
Hyphema
2
2
Hypopyon
2
2
Hemorrhage/Bleeding
2
2
Keratitis
2
2
Retinal Detachment
2
2
Retinal Tear
2
2
Scar Tissue
2
2
Sunset Syndrome
1
1
Bacterial Infection
1
1
Intraocular Infection
1
1
Corneal Ulcer
1
1
Edema
1
1
Chemosis
1
1
Loss of Vision
1
1
Anxiety
1
1
Distress
1
1
Clouding, Central Corneal
1
1
Vitreous Hemorrhage
1
1
Twitching
1
1
Vertigo
1
1
UGH (Uveitis Glaucoma Hyphema) Syndrome
1
1
Vitreous Detachment
1
1
Depression
1
1
Impaired Healing
1
1
Foreign Body In Patient
1
1
Eye Infections
1
1
Dry Mouth
1
1
Decreased Appetite
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Johnson & Johnson Surgical Vision, Inc.
II
Aug-03-2023
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