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TPLC
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Device
extended depth of focus intraocular lens
Regulation Description
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)
2020
2021
2022
2023
2024
2025
3
1
6
3
0
0
MDR Year
MDR Reports
MDR Events
2020
347
358
2021
598
599
2022
635
635
2023
552
552
2024
565
580
2025
35
35
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1737
1747
Scratched Material
233
233
Device Dislodged or Dislocated
104
104
Defective Device
103
103
Break
97
109
Appropriate Term/Code Not Available
74
74
Crack
59
59
Device Contamination with Chemical or Other Material
39
39
Malposition of Device
36
36
Unstable
34
34
Material Opacification
27
27
Material Split, Cut or Torn
26
26
Defective Component
24
24
Failure to Eject
24
24
Unintended Movement
24
24
Insufficient Information
20
20
Device Damaged by Another Device
18
18
Failure to Advance
15
15
Optical Decentration
13
13
Application Program Problem: Power Calculation Error
12
12
Use of Device Problem
11
11
Contamination
10
10
Inaccurate Delivery
8
8
Material Fragmentation
8
8
Mechanical Problem
8
8
Material Discolored
8
8
Device Markings/Labelling Problem
7
7
Patient-Device Incompatibility
7
7
Failure to Unfold or Unwrap
7
7
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Difficult to Fold, Unfold or Collapse
6
6
Application Program Problem: Dose Calculation Error
6
6
Material Twisted/Bent
5
5
Device Difficult to Setup or Prepare
5
5
Product Quality Problem
5
5
Structural Problem
5
5
Material Deformation
5
5
Failure to Fold
4
4
Physical Resistance/Sticking
4
5
Failure to Align
4
4
Mechanical Jam
3
3
Difficult to Insert
3
3
Nonstandard Device
3
3
Labelling, Instructions for Use or Training Problem
3
3
Device Contaminated During Manufacture or Shipping
2
2
Positioning Problem
2
2
Positioning Failure
2
2
Ejection Problem
2
2
Patient Device Interaction Problem
2
2
Difficult to Advance
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Blurred Vision
957
958
Visual Impairment
691
691
Visual Disturbances
678
684
No Clinical Signs, Symptoms or Conditions
362
363
Halo
359
361
Insufficient Information
355
355
No Code Available
262
262
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
202
202
Dry Eye(s)
78
78
Flashers
57
59
Discomfort
56
56
Headache
51
51
Eye Pain
47
47
Corneal Edema
44
44
Eye Injury
42
42
Inflammation
40
40
Therapeutic Effects, Unexpected
36
36
Capsular Bag Tear
31
31
Vitreous Floaters
29
29
Macular Edema
24
24
Unspecified Eye / Vision Problem
21
21
Dizziness
16
16
Nausea
14
14
Vitrectomy
14
14
No Consequences Or Impact To Patient
13
25
Intraocular Pressure Increased
13
13
Foreign Body Sensation in Eye
11
11
Excessive Tear Production
10
10
Uveitis
10
10
Pain
9
9
Zonular Dehiscence
8
8
Endophthalmitis
8
8
Conjunctivitis
7
7
No Known Impact Or Consequence To Patient
6
6
Swelling/ Edema
6
6
Itching Sensation
6
6
Toxic Anterior Segment Syndrome (TASS)
6
6
Irritability
6
6
Unspecified Infection
5
5
Iritis
5
5
Red Eye(s)
5
5
Failure of Implant
4
4
Fibrosis
3
3
Balance Problems
3
3
Intraocular Pressure Decreased
3
3
Vitreous Detachment
3
3
Retinal Tear
3
3
Unspecified Tissue Injury
3
3
Hypersensitivity/Allergic reaction
3
3
Hemorrhage/Bleeding
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Johnson & Johnson Surgical Vision, Inc.
II
Aug-03-2023
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