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TPLC
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show TPLC since
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2024
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Device
aid, surgical, viscoelastic
Product Code
LZP
Regulation Number
886.4275
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
5
13
15
8
13
0
MDR Year
MDR Reports
MDR Events
2019
156
156
2020
132
132
2021
157
157
2022
184
184
2023
107
107
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
450
450
Contamination
118
118
Appropriate Term/Code Not Available
32
32
Device Contaminated During Manufacture or Shipping
22
22
Detachment of Device or Device Component
18
18
Difficult to Remove
16
16
Particulates
15
15
Mechanical Problem
14
14
Device Contamination with Chemical or Other Material
13
13
Manufacturing, Packaging or Shipping Problem
11
11
Delivered as Unsterile Product
10
10
Separation Problem
6
6
Product Quality Problem
4
4
Positioning Problem
4
4
Contamination /Decontamination Problem
4
4
Obstruction of Flow
3
3
Failure to Align
2
2
Patient-Device Incompatibility
2
2
Material Deformation
2
2
Material Separation
2
2
Break
2
2
Physical Resistance/Sticking
2
2
Operating System Becomes Nonfunctional
2
2
Device Handling Problem
1
1
Sharp Edges
1
1
Device Contaminated at the User Facility
1
1
Complete Blockage
1
1
Coagulation in Device or Device Ingredient
1
1
Crack
1
1
Leak/Splash
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Defective Component
1
1
Fungus in Device Environment
1
1
Tear, Rip or Hole in Device Packaging
1
1
Therapy Delivered to Incorrect Body Area
1
1
Precipitate in Device or Device Ingredient
1
1
Material Integrity Problem
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Human-Device Interface Problem
1
1
Device Dislodged or Dislocated
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Intraocular Pressure Increased
172
172
No Clinical Signs, Symptoms or Conditions
139
139
Toxic Anterior Segment Syndrome (TASS)
100
100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
88
88
Endophthalmitis
63
63
Inflammation
59
59
Corneal Edema
55
55
No Code Available
51
51
Uveitis
51
51
No Consequences Or Impact To Patient
50
50
Blurred Vision
40
40
Capsular Bag Tear
29
29
No Known Impact Or Consequence To Patient
28
28
Eye Burn
27
27
Visual Impairment
22
22
Hyphema
22
22
Hypopyon
18
18
Pain
18
18
Eye Injury
17
17
Eye Pain
16
16
Conjunctivitis
15
15
Loss of Vision
13
13
No Information
12
12
Foreign Body In Patient
10
10
Vitritis
8
8
Intraocular Pressure Decreased
8
8
Hemorrhage/Bleeding
8
8
Iritis
8
8
Vitrectomy
7
7
Fibrosis
7
7
Nausea
6
6
Vitreous Floaters
5
5
Clouding, Central Corneal
5
5
Rupture
4
4
Visual Disturbances
4
4
No Patient Involvement
4
4
Eye Infections
4
4
Macular Edema
4
4
Keratitis
4
4
Cataract
3
3
Unspecified Infection
3
3
Corneal Clouding/Hazing
3
3
Headache
3
3
Corneal Decompensation
3
3
Corneal Stromal Edema
2
2
Bacterial Infection
2
2
Glaucoma
2
2
Intraocular Infection
2
2
Intraocular Pressure, Delayed, Uncontrolled
2
2
Perforation
2
2
Red Eye(s)
2
2
Retinal Detachment
2
2
Swelling/ Edema
2
2
Zonular Dehiscence
2
2
Vitreous Loss
2
2
Vitreous Hemorrhage
2
2
Vomiting
2
2
Burning Sensation
1
1
Burn, Thermal
1
1
Excessive Tear Production
1
1
Anxiety
1
1
Discomfort
1
1
Injury
1
1
Reaction
1
1
Device Embedded In Tissue or Plaque
1
1
Insufficient Information
1
1
Respiratory Insufficiency
1
1
Occlusion
1
1
Irritation
1
1
Hyperemia
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Capsular Contracture
1
1
Adhesion(s)
1
1
Autoimmune Reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Johnson & Johnson Surgical Vision Inc
II
Jan-27-2020
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