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TPLC
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show TPLC since
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2025
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Device
lens, intraocular, toric optics
Regulation Description
Intraocular lens.
Product Code
MJP
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
1
0
0
0
0
0
MDR Year
MDR Reports
MDR Events
2020
211
211
2021
285
288
2022
513
513
2023
748
748
2024
1101
1156
2025
790
826
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1287
1308
Scratched Material
381
383
Break
376
391
Material Discolored
250
250
Device Dislodged or Dislocated
178
178
Defective Device
170
170
Crack
134
134
Unstable
116
116
Malposition of Device
94
94
Material Split, Cut or Torn
90
91
Device Difficult to Setup or Prepare
66
67
Failure to Eject
61
61
Appropriate Term/Code Not Available
58
58
Material Fragmentation
55
55
Failure to Advance
48
50
Device Contamination with Chemical or Other Material
47
47
Mechanical Jam
46
47
Material Opacification
44
44
Device Damaged by Another Device
40
40
Failure to Deliver
40
40
Material Twisted/Bent
36
36
Ejection Problem
35
35
Defective Component
32
32
Contamination
30
31
Inaccurate Delivery
28
28
Mechanical Problem
26
27
Product Quality Problem
26
26
Unintended Movement
22
22
Insufficient Information
22
22
Material Deformation
20
20
Difficult to Fold, Unfold or Collapse
19
19
Failure to Unfold or Unwrap
19
19
Operating System Becomes Nonfunctional
15
15
Application Program Problem: Power Calculation Error
12
12
Failure to Fold
12
12
Physical Resistance/Sticking
12
12
Optical Decentration
11
11
Unintended Ejection
10
10
Use of Device Problem
10
10
Delivered as Unsterile Product
9
9
Difficult to Insert
9
9
Device Markings/Labelling Problem
9
9
Particulates
9
9
Device Contaminated During Manufacture or Shipping
8
8
Manufacturing, Packaging or Shipping Problem
8
8
Failure to Align
8
8
Application Program Problem: Dose Calculation Error
8
8
Patient-Device Incompatibility
7
7
Positioning Problem
7
7
Device Damaged Prior to Use
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1159
1193
Blurred Vision
769
774
Insufficient Information
740
740
Visual Impairment
703
709
Visual Disturbances
398
400
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
184
186
Halo
132
132
Capsular Bag Tear
83
84
Corneal Edema
64
64
Eye Injury
62
63
No Known Impact Or Consequence To Patient
55
55
Eye Pain
42
42
Inflammation
40
40
No Code Available
38
38
Dry Eye(s)
36
37
Discomfort
32
32
Vitreous Floaters
31
31
Headache
29
29
Intraocular Pressure Increased
27
27
Endophthalmitis
22
22
Toxic Anterior Segment Syndrome (TASS)
16
16
Macular Edema
15
15
Red Eye(s)
14
14
Zonular Dehiscence
14
14
No Consequences Or Impact To Patient
12
15
Uveitis
10
10
Loss of Vision
10
10
Dizziness
10
10
Flashers
10
10
Excessive Tear Production
9
9
Vitreous Loss
9
9
Hypopyon
9
9
Failure of Implant
9
9
Fibrosis
8
8
Therapeutic Effects, Unexpected
7
7
Swelling/ Edema
7
8
Unspecified Eye / Vision Problem
7
7
Foreign Body Sensation in Eye
7
7
Conjunctivitis
6
6
Retinal Detachment
6
6
Corneal Clouding/Hazing
5
5
Nausea
5
5
Itching Sensation
4
4
Adhesion(s)
4
4
Vitrectomy
4
4
Pain
4
4
Hyperemia
4
4
No Information
4
4
Eye Infections
4
4
Vitreous Detachment
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Bausch & Lomb Surgical, Inc.
II
Dec-02-2020
2
Johnson & Johnson Surgical Vision Inc
II
Oct-04-2021
3
Johnson & Johnson Surgical Vision Inc
II
Mar-03-2021
4
Johnson & Johnson Surgical Vision, Inc.
II
Jan-16-2024
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