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TPLC
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Device
aid, surgical, viscoelastic
Regulation Description
Intraocular fluid.
Product Code
LZP
Regulation Number
886.4275
Device Class
3
Premarket Approvals (PMA)
2020
2021
2022
2023
2024
2025
13
15
8
13
10
6
MDR Year
MDR Reports
MDR Events
2020
132
132
2021
157
157
2022
184
184
2023
107
107
2024
96
107
2025
34
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
439
440
Contamination
110
120
Appropriate Term/Code Not Available
29
29
Device Contaminated During Manufacture or Shipping
22
22
Detachment of Device or Device Component
18
18
Particulates
17
17
Manufacturing, Packaging or Shipping Problem
14
14
Mechanical Problem
13
15
Delivered as Unsterile Product
12
12
Device Contamination with Chemical or Other Material
12
12
Difficult to Remove
7
7
Positioning Problem
4
4
Fitting Problem
3
3
Obstruction of Flow
3
3
Product Quality Problem
3
3
Operating System Becomes Nonfunctional
2
2
Break
2
2
Physical Resistance/Sticking
2
2
Defective Component
2
2
Use of Device Problem
2
3
Failure to Align
2
2
Material Separation
2
2
Leak/Splash
1
1
Separation Problem
1
1
Crack
1
1
Complete Blockage
1
1
Patient-Device Incompatibility
1
1
Insufficient Information
1
1
Expiration Date Error
1
2
Material Integrity Problem
1
1
Contamination /Decontamination Problem
1
1
Air/Gas in Device
1
1
Precipitate in Device or Device Ingredient
1
1
Sharp Edges
1
1
Material Deformation
1
1
No Apparent Adverse Event
1
1
Device Dislodged or Dislocated
1
1
Coagulation in Device or Device Ingredient
1
1
Connection Problem
1
1
Device Contaminated at the User Facility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
171
183
Intraocular Pressure Increased
128
128
Toxic Anterior Segment Syndrome (TASS)
118
118
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
102
102
Endophthalmitis
79
79
Inflammation
66
66
Corneal Edema
65
65
Blurred Vision
62
62
Uveitis
59
59
No Consequences Or Impact To Patient
34
34
Hypopyon
33
33
Eye Burn
30
30
Eye Pain
23
23
No Code Available
23
23
Hyphema
23
24
Capsular Bag Tear
22
22
Loss of Vision
20
20
Visual Impairment
20
20
Eye Injury
19
20
Vitritis
18
18
Conjunctivitis
14
14
Iritis
12
12
No Information
12
12
Intraocular Pressure Decreased
11
11
Vitreous Floaters
9
9
Hyperemia
7
7
Fibrosis
7
7
Insufficient Information
7
7
No Known Impact Or Consequence To Patient
7
7
Headache
6
6
Pain
6
6
Foreign Body In Patient
6
6
Corneal Clouding/Hazing
6
6
Vitrectomy
5
5
Clouding, Central Corneal
5
5
Keratitis
5
5
Hemorrhage/Bleeding
5
5
Macular Edema
5
5
Retinal Detachment
4
4
Swelling/ Edema
4
4
Vitreous Hemorrhage
4
4
Eye Infections
4
4
Zonular Dehiscence
3
3
Visual Disturbances
3
3
Rupture
3
3
Cataract
3
3
Excessive Tear Production
2
2
Retinal Tear
2
2
Unspecified Infection
2
2
Corneal Perforation
2
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Johnson & Johnson Surgical Vision Inc
II
Jan-27-2020
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