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TPLC
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Device
instrument, vitreous aspiration and cutting, ac-powered
Product Code
HQE
Regulation Number
886.4150
Device Class
2
Premarket Reviews
Manufacturer
Decision
VISIONCARE DEVICES, LLC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
309
309
2019
41
41
2020
30
30
2021
32
32
2022
46
46
2023
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fitting Problem
146
146
Difficult to Insert
85
85
Device Operational Issue
72
72
Failure to Advance
22
22
Sticking
19
19
Physical Resistance/Sticking
14
14
Failure to Cut
13
13
Device Operates Differently Than Expected
12
12
Material Separation
10
10
Particulates
7
7
Defective Component
7
7
Detachment of Device or Device Component
7
7
Device Contamination with Chemical or Other Material
7
7
Material Deformation
6
6
Material Integrity Problem
6
6
Adverse Event Without Identified Device or Use Problem
5
5
Physical Property Issue
5
5
Mechanical Problem
5
5
Entrapment of Device
5
5
Fluid/Blood Leak
4
4
Inadequacy of Device Shape and/or Size
4
4
Energy Output Problem
4
4
Material Twisted/Bent
4
4
Contamination /Decontamination Problem
4
4
Connection Problem
4
4
Difficult to Remove
4
4
Noise, Audible
3
3
Positioning Problem
3
3
Power Problem
3
3
Display or Visual Feedback Problem
3
3
Break
3
3
Detachment Of Device Component
2
2
Air Leak
2
2
Material Fragmentation
2
2
Loose or Intermittent Connection
2
2
Delivered as Unsterile Product
2
2
Device Inoperable
2
2
Mechanical Jam
2
2
No Flow
2
2
Structural Problem
2
2
Physical Resistance
2
2
Device Displays Incorrect Message
2
2
Device Dislodged or Dislocated
2
2
Infusion or Flow Problem
2
2
Device Fell
1
1
Suction Failure
1
1
Device-Device Incompatibility
1
1
Difficult to Advance
1
1
Activation, Positioning or Separation Problem
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Failure to Fire
1
1
Defective Device
1
1
Material Split, Cut or Torn
1
1
Gas/Air Leak
1
1
Pressure Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Use of Device Problem
1
1
Suction Problem
1
1
Insufficient Flow or Under Infusion
1
1
Inaccurate Delivery
1
1
Device Damaged Prior to Use
1
1
Unsealed Device Packaging
1
1
Smoking
1
1
Failure to Power Up
1
1
Incorrect Measurement
1
1
Migration or Expulsion of Device
1
1
Inability to Irrigate
1
1
Partial Blockage
1
1
Loss of or Failure to Bond
1
1
Filling Problem
1
1
Component Incompatible
1
1
Crack
1
1
Disconnection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
183
183
No Known Impact Or Consequence To Patient
149
149
No Clinical Signs, Symptoms or Conditions
109
109
Intraocular Pressure, Delayed, Uncontrolled
8
8
Hemorrhage/Bleeding
6
6
No Patient Involvement
6
6
Foreign Body In Patient
6
6
No Information
5
5
No Code Available
4
4
Device Embedded In Tissue or Plaque
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Eye Injury
4
4
Retinal Injury
3
3
Insufficient Information
3
3
Capsular Bag Tear
2
2
Loss of Vision
2
2
Retinal Detachment
2
2
Intraocular Pressure Increased
1
1
Foreign Body Sensation in Eye
1
1
Hematoma
1
1
Corneal Edema
1
1
Endophthalmitis
1
1
Retinal Degeneration
1
1
Retinal Tear
1
1
Thrombus
1
1
Complaint, Ill-Defined
1
1
Injury
1
1
Eye Burn
1
1
Vitritis
1
1
Intraocular Pressure Decreased
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bausch & Lomb Inc
II
Sep-27-2018
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