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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
aid, surgical, viscoelastic
Product Code
LZP
Regulation Number
886.4275
Device Class
3
Premarket Approvals (PMA)
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
11
12
18
8
5
13
15
8
13
8
MDR Year
MDR Reports
MDR Events
2015
68
68
2016
136
136
2017
162
162
2018
113
113
2019
156
156
2020
132
132
2021
157
157
2022
184
184
2023
107
107
2024
53
55
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
619
619
Contamination
134
136
Device Contamination with Chemical or Other Material
128
128
Insufficient Information
83
83
Appropriate Term/Code Not Available
48
48
Detachment of Device or Device Component
30
30
Device Contaminated During Manufacture or Shipping
22
22
Particulates
20
20
Difficult to Remove
18
18
Leak/Splash
17
17
Disconnection
16
16
Mechanical Problem
14
14
Detachment Of Device Component
13
13
Device Operates Differently Than Expected
13
13
Patient-Device Incompatibility
12
12
Contamination /Decontamination Problem
12
12
Delivered as Unsterile Product
12
12
Manufacturing, Packaging or Shipping Problem
11
11
Separation Problem
7
7
Break
7
7
Product Quality Problem
5
5
Device Markings/Labelling Problem
5
5
Positioning Problem
5
5
Device Handling Problem
5
5
Use of Device Problem
4
4
Material Integrity Problem
3
3
Contamination of Device Ingredient or Reagent
3
3
Obstruction of Flow
3
3
Temperature Problem
2
2
Connection Problem
2
2
Material Separation
2
2
Complete Blockage
2
2
Material Opacification
2
2
Burst Container or Vessel
2
2
Physical Resistance/Sticking
2
2
Improper or Incorrect Procedure or Method
2
2
Use of Incorrect Control/Treatment Settings
2
2
Packaging Problem
2
2
Material Deformation
2
2
Material Fragmentation
2
2
Failure to Align
2
2
Operating System Becomes Nonfunctional
2
2
Occlusion Within Device
2
2
Split
2
2
Component Missing
2
2
Microbial Contamination of Device
2
2
Defective Component
2
2
Therapy Delivered to Incorrect Body Area
1
1
Component Falling
1
1
Fitting Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Intraocular Pressure Increased
215
215
No Clinical Signs, Symptoms or Conditions
154
156
No Consequences Or Impact To Patient
150
150
Inflammation
130
130
Toxic Anterior Segment Syndrome (TASS)
107
107
No Code Available
105
105
Corneal Edema
101
101
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
94
94
Endophthalmitis
92
92
No Known Impact Or Consequence To Patient
83
83
Uveitis
56
56
Blurred Vision
50
50
Capsular Bag Tear
43
43
Pain
37
37
Eye Burn
34
34
Visual Impairment
33
33
Toxicity
30
30
Eye Injury
27
27
Hyphema
24
24
Loss of Vision
24
24
Foreign Body In Patient
23
23
Hypopyon
23
23
Vitrectomy
22
22
No Information
19
19
Eye Pain
19
19
Conjunctivitis
15
15
No Patient Involvement
15
15
Unspecified Infection
14
14
Clouding, Central Corneal
12
12
Hemorrhage/Bleeding
11
11
Iritis
11
11
Intraocular Pressure Decreased
10
10
Headache
9
9
Vitreous Loss
9
9
Vitritis
9
9
Fibrosis
8
8
Macular Edema
8
8
Vitreous Floaters
8
8
Red Eye(s)
8
8
Corneal Decompensation
7
7
Rupture
7
7
Visual Disturbances
7
7
Reaction
7
7
Keratitis
6
6
Nausea
6
6
Irritation
6
6
Vitreous Hemorrhage
6
6
Bacterial Infection
5
5
Burn, Thermal
5
5
Injury
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott Medical Optics Inc. (AMO)
II
May-10-2017
2
Johnson & Johnson Surgical Vision Inc
II
Jan-27-2020
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