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TPLC
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show TPLC since
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Device
intraocular lens
Product Code
HQL
Regulation Number
886.3600
Device Class
3
Premarket Approvals (PMA)
2017
2018
2019
2020
2021
2022
41
39
57
49
54
20
MDR Year
MDR Reports
MDR Events
2017
2386
2386
2018
2499
2499
2019
3086
3603
2020
1982
3097
2021
2929
3100
2022
1971
1971
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
3498
3498
Break
2660
4096
Scratched Material
985
1049
Crack
638
780
Device Contamination with Chemical or Other Material
473
473
Appropriate Term/Code Not Available
461
461
Material Opacification
369
369
Device Operates Differently Than Expected
359
359
Defective Device
352
352
Unintended Movement
350
350
Material Split, Cut or Torn
344
344
Contamination
332
332
Failure to Eject
331
331
Device Dislodged or Dislocated
309
309
Inaccurate Delivery
265
265
Insufficient Information
246
246
No Apparent Adverse Event
217
217
Material Fragmentation
206
206
Failure to Unfold or Unwrap
183
183
Failure to Advance
182
182
Mechanical Jam
179
179
Difficult to Fold, Unfold or Collapse
167
167
Inadequacy of Device Shape and/or Size
165
165
Material Twisted/Bent
165
165
Contamination /Decontamination Problem
163
163
Physical Resistance/Sticking
162
162
Defective Component
139
254
Material Deformation
138
138
Positioning Failure
118
118
Sticking
117
117
Difficult or Delayed Positioning
115
115
Torn Material
102
102
Failure to Fold
100
100
Use of Device Problem
91
91
Positioning Problem
89
89
Device Damaged by Another Device
85
131
Difficult to Advance
85
85
Patient-Device Incompatibility
85
85
Device Contaminated During Manufacture or Shipping
80
80
Malposition of Device
78
78
Material Integrity Problem
75
75
Bent
74
74
Device Handling Problem
72
72
Mechanical Problem
71
71
Premature Activation
68
68
Separation Problem
67
67
Product Quality Problem
64
64
Calcified
64
64
Improper or Incorrect Procedure or Method
62
62
Material Discolored
57
57
Difficult to Insert
55
55
Material Too Rigid or Stiff
54
54
Detachment Of Device Component
53
53
Detachment of Device or Device Component
50
50
Split
46
46
Unstable
46
46
Activation, Positioning or SeparationProblem
45
45
Device Difficult to Setup or Prepare
45
45
Optical Problem
44
44
Operating System Becomes Nonfunctional
42
42
Unexpected Therapeutic Results
41
41
Fracture
41
41
Entrapment of Device
41
41
Ejection Problem
39
39
Delivered as Unsterile Product
37
37
Device Markings/Labelling Problem
36
36
Device Damaged Prior to Use
32
32
Manufacturing, Packaging or Shipping Problem
31
31
Material Rupture
28
28
Migration or Expulsion of Device
26
26
Device Appears to Trigger Rejection
25
25
Off-Label Use
25
25
Optical Distortion
22
22
Sharp Edges
22
22
Deformation Due to Compressive Stress
21
21
Unintended Ejection
21
21
Structural Problem
20
20
Therapeutic or Diagnostic Output Failure
20
43
Failure to Align
19
19
Dent in Material
18
18
Material Separation
15
15
Failure to Deliver
14
14
Component Missing
13
13
Incorrect, Inadequate or Imprecise Resultor Readings
13
13
Hole In Material
12
12
Folded
12
12
Packaging Problem
12
12
Inaccurate Information
12
12
Patient Device Interaction Problem
10
10
Material Protrusion/Extrusion
10
10
Contamination of Device Ingredient or Reagent
10
10
Kinked
10
10
Particulates
10
10
Optical Decentration
9
9
Material Frayed
9
9
Difficult To Position
8
8
Misfocusing
8
8
Device Slipped
8
8
Output Problem
8
8
Material Distortion
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2852
2882
No Code Available
2811
2811
No Known Impact Or Consequence To Patient
2248
2433
No Consequences Or Impact To Patient
1706
3278
Visual Impairment
1058
1058
Capsular Bag Tear
848
848
No Patient Involvement
843
843
Blurred Vision
788
789
Visual Disturbances
673
673
Vitrectomy
560
560
Insufficient Information
505
538
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
383
383
Halo
245
245
Failure of Implant
215
215
Inflammation
213
213
Corneal Edema
185
185
No Information
185
185
Eye Injury
184
184
Endophthalmitis
146
146
Intraocular Pressure Increased
95
95
Pain
80
80
Discomfort
75
75
Therapeutic Effects, Unexpected
69
69
Loss of Vision
65
65
Dry Eye(s)
52
52
Vitreous Loss
50
50
Toxic Anterior Segment Syndrome (TASS)
49
49
Uveitis
47
47
Unspecified Infection
44
44
Hemorrhage/Bleeding
43
43
Macular Edema
43
43
Rupture
43
43
Foreign Body In Patient
38
38
Eye Pain
36
36
Vitreous Floaters
35
35
Edema
34
34
Red Eye(s)
33
33
Zonular Dehiscence
32
32
Iritis
30
30
Flashers
30
30
Retinal Detachment
28
28
Glaucoma
26
26
Hypopyon
25
25
Foreign Body Sensation in Eye
25
25
Corneal Clouding/Hazing
24
24
Hyphema
23
23
Irritation
19
19
Fibrosis
16
16
Patient Problem/Medical Problem
16
16
Swelling
15
16
Tissue Damage
14
14
Vitreous Hemorrhage
13
13
Complaint, Ill-Defined
13
13
Reaction
13
13
Deposits
13
13
Headache
12
12
Dizziness
12
12
Excessive Tear Production
12
12
Nausea
11
11
Calcium Deposits/Calcification
11
11
Capsular Contracture
11
11
Erythema
10
10
Retinal Tear
10
10
Injury
10
10
Burning Sensation
10
10
Prolapse
10
10
Vitreous Detachment
9
9
UGH (Uveitis-Glaucoma-Hyphema) Syndrome
9
9
Discharge
9
9
Bacterial Infection
9
9
Increased Sensitivity
8
8
Hyperemia
8
8
Therapeutic Response, Decreased
8
8
Corneal Decompensation
7
7
Swelling/ Edema
7
7
Conjunctivitis
6
6
Corneal Abrasion
6
6
High Blood Pressure/ Hypertension
6
6
Intraocular Infection
6
6
Intraocular Pressure Decreased
6
6
Eye Infections
6
6
Unspecified Eye / Vision Problem
6
6
Impaired Healing
5
5
Scarring
5
5
Cataract
5
5
Wound Dehiscence
4
4
Adhesion(s)
4
4
Itching Sensation
4
4
Keratitis
4
4
Laceration(s)
4
4
Anxiety
4
4
Inadequate Pain Relief
4
4
Disability
4
4
Blood Loss
4
4
Collapse
3
3
UGH (Uveitis Glaucoma Hyphema) Syndrome
3
3
Device Embedded In Tissue or Plaque
3
3
Clouding, Central Corneal
3
3
Toxicity
3
3
Vitritis
3
3
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.
II
Jul-10-2020
4
Bausch & Lomb Surgical, Inc.
II
Dec-18-2018
5
Johnson & Johnson Surgical Vision Inc
II
Nov-14-2018
6
Rayner Intraocular Lenses Limited
II
Sep-28-2018
7
Rayner Intraocular Lenses Ltd
II
Jul-06-2022
8
Tekia, Inc.
II
Dec-17-2019
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