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TPLC
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show TPLC since
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Device
aid, surgical, viscoelastic
Product Code
LZP
Regulation Number
886.4275
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
8
5
13
15
8
2
MDR Year
MDR Reports
MDR Events
2018
113
113
2019
156
156
2020
132
132
2021
157
157
2022
184
184
2023
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
453
453
Contamination
96
96
Appropriate Term/Code Not Available
33
33
Detachment of Device or Device Component
24
24
Device Contamination with Chemical or Other Material
23
23
Device Contaminated During Manufacture or Shipping
22
22
Difficult to Remove
18
18
Particulates
14
14
Mechanical Problem
13
13
Leak/Splash
12
12
Contamination /Decontamination Problem
12
12
Disconnection
11
11
Insufficient Information
11
11
Delivered as Unsterile Product
10
10
Manufacturing, Packaging or Shipping Problem
9
9
Separation Problem
7
7
Positioning Problem
4
4
Product Quality Problem
4
4
Break
4
4
Obstruction of Flow
3
3
Failure to Align
2
2
Patient-Device Incompatibility
2
2
Material Separation
2
2
Material Deformation
2
2
Detachment Of Device Component
2
2
Operating System Becomes Nonfunctional
2
2
Device Handling Problem
2
2
Physical Resistance/Sticking
2
2
Sharp Edges
1
1
Packaging Problem
1
1
Human-Device Interface Problem
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Device Contaminated at the User Facility
1
1
Unintended Ejection
1
1
Burst Container or Vessel
1
1
Coagulation in Device or Device Ingredient
1
1
Crack
1
1
Therapy Delivered to Incorrect Body Area
1
1
Precipitate in Device or Device Ingredient
1
1
Occlusion Within Device
1
1
Device Emits Odor
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Material Integrity Problem
1
1
Connection Problem
1
1
Contamination of Device Ingredient or Reagent
1
1
Device Operates Differently Than Expected
1
1
Fungus in Device Environment
1
1
Tear, Rip or Hole in Device Packaging
1
1
Structural Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Intraocular Pressure Increased
180
180
No Clinical Signs, Symptoms or Conditions
102
102
Toxic Anterior Segment Syndrome (TASS)
98
98
No Consequences Or Impact To Patient
81
81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
76
76
No Code Available
71
71
Inflammation
63
63
Corneal Edema
59
59
Endophthalmitis
55
55
Uveitis
52
52
No Known Impact Or Consequence To Patient
41
41
Blurred Vision
35
35
Eye Burn
26
26
Capsular Bag Tear
26
26
Eye Injury
21
21
Hyphema
21
21
Pain
21
21
Visual Impairment
20
20
Hypopyon
15
15
Loss of Vision
12
12
No Information
12
12
Eye Pain
11
11
Clouding, Central Corneal
11
11
Conjunctivitis
11
11
Vitrectomy
9
9
Foreign Body In Patient
9
9
Vitritis
8
8
Hemorrhage/Bleeding
8
8
Unspecified Infection
7
7
No Patient Involvement
7
7
Intraocular Pressure Decreased
7
7
Nausea
6
6
Corneal Decompensation
6
6
Iritis
5
5
Irritation
5
5
Rupture
5
5
Visual Disturbances
4
4
Vitreous Loss
4
4
Eye Infections
4
4
Headache
4
4
Corneal Clouding/Hazing
3
3
Macular Edema
3
3
Burn, Thermal
3
3
Vitreous Hemorrhage
3
3
Toxicity
3
3
Injury
2
2
Retinal Detachment
2
2
Vomiting
2
2
Fibrosis
2
2
Swelling/ Edema
2
2
Corneal Stromal Edema
2
2
Vitreous Floaters
2
2
Corneal Abrasion
2
2
Intraocular Pressure, Delayed, Uncontrolled
2
2
Keratitis
2
2
Perforation
2
2
Red Eye(s)
1
1
Occlusion
1
1
Intraocular Infection
1
1
Hypersensitivity/Allergic reaction
1
1
High Blood Pressure/ Hypertension
1
1
Edema
1
1
Adhesion(s)
1
1
Autoimmune Reaction
1
1
Burn(s)
1
1
Capsular Contracture
1
1
Cataract
1
1
Glaucoma
1
1
Insufficient Information
1
1
Blood Loss
1
1
Zonular Dehiscence
1
1
Device Embedded In Tissue or Plaque
1
1
Burning Sensation
1
1
Toxic Shock Syndrome
1
1
Reaction
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Johnson & Johnson Surgical Vision Inc
II
Jan-27-2020
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