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TPLC
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show TPLC since
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Device
intraocular lens
Regulation Description
Intraocular lens.
Product Code
HQL
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
49
53
34
29
35
17
MDR Year
MDR Reports
MDR Events
2020
1981
3096
2021
2925
3096
2022
3290
3290
2023
3908
3956
2024
3201
4169
2025
1641
2282
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3611
5094
Adverse Event Without Identified Device or Use Problem
3107
3285
Scratched Material
1703
1835
Material Split, Cut or Torn
1138
1143
Crack
969
1080
Defective Device
788
788
Failure to Eject
734
734
Material Fragmentation
505
520
Failure to Advance
462
463
Contamination
459
478
Use of Device Problem
438
440
Material Opacification
400
404
Device Dislodged or Dislocated
386
389
Inaccurate Delivery
379
379
Appropriate Term/Code Not Available
350
352
Device Damaged by Another Device
320
366
Device Difficult to Setup or Prepare
319
328
Ejection Problem
294
312
Material Twisted/Bent
293
293
Mechanical Jam
268
278
Difficult to Fold, Unfold or Collapse
262
267
Off-Label Use
247
247
Failure to Unfold or Unwrap
240
240
Device Contamination with Chemical or Other Material
229
229
Defective Component
220
335
Physical Resistance/Sticking
188
200
Failure to Fold
187
188
Insufficient Information
167
167
Failure to Deliver
149
149
Mechanical Problem
125
126
Material Discolored
123
123
Material Integrity Problem
115
115
Material Deformation
99
99
Difficult to Advance
96
96
Product Quality Problem
95
95
Unintended Ejection
89
89
Malposition of Device
87
87
Device Contaminated During Manufacture or Shipping
82
82
Delivered as Unsterile Product
80
81
Operating System Becomes Nonfunctional
78
79
Unintended Movement
74
74
Sharp Edges
71
71
Contamination /Decontamination Problem
69
69
Difficult to Insert
68
69
No Apparent Adverse Event
59
59
Manufacturing, Packaging or Shipping Problem
55
56
Material Too Rigid or Stiff
50
50
Device Appears to Trigger Rejection
49
49
Device Handling Problem
49
49
Optical Problem
49
49
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7430
8591
Insufficient Information
3122
3155
Visual Impairment
1387
1400
Blurred Vision
927
940
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
901
977
Visual Disturbances
824
845
Capsular Bag Tear
785
795
No Code Available
630
630
Failure of Implant
606
606
Eye Injury
404
416
No Known Impact Or Consequence To Patient
400
579
No Consequences Or Impact To Patient
367
1428
Halo
255
256
Inflammation
221
221
Corneal Edema
219
221
Endophthalmitis
148
155
Toxic Anterior Segment Syndrome (TASS)
141
141
Vitrectomy
129
129
Eye Pain
126
126
Intraocular Pressure Increased
123
171
Discomfort
92
94
Uveitis
74
123
Flashers
69
71
Zonular Dehiscence
66
66
Dry Eye(s)
63
65
Therapeutic Effects, Unexpected
61
61
Macular Edema
59
107
Vitreous Floaters
53
54
Retinal Detachment
47
95
Vitreous Loss
42
42
Hypopyon
42
42
Red Eye(s)
41
41
No Patient Involvement
41
41
Unspecified Eye / Vision Problem
40
43
Hyphema
35
36
Iritis
33
33
Glaucoma
32
32
Fibrosis
31
31
Headache
27
29
Swelling/ Edema
26
26
Pain
25
26
Foreign Body Sensation in Eye
25
26
Vitreous Hemorrhage
23
23
Eye Infections
23
24
Keratitis
21
21
Hemorrhage/Bleeding
21
21
Foreign Body In Patient
21
21
Corneal Clouding/Hazing
21
21
Prolapse
19
19
Loss of Vision
18
18
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.
I
May-02-2025
4
Bausch & Lomb Surgical, Inc.
II
Jul-10-2020
5
Johnson & Johnson Surgical Vision, Inc.
II
Aug-03-2023
6
Rayner Intraocular Lenses Ltd
II
Jul-06-2022
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