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TPLC
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show TPLC since
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Device
cannula, ophthalmic
Product Code
HMX
Regulation Number
886.4350
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
38
38
2019
27
27
2020
27
27
2021
41
41
2022
46
46
2023
91
91
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
59
59
Particulates
25
25
Adverse Event Without Identified Device or Use Problem
21
21
Fitting Problem
20
20
Complete Blockage
20
20
Break
14
14
Obstruction of Flow
14
14
Device Contamination with Chemical or Other Material
10
10
Contamination /Decontamination Problem
8
8
Material Separation
8
8
Insufficient Information
7
7
Material Opacification
6
6
Connection Problem
4
4
Activation, Positioning or Separation Problem
4
4
Detachment Of Device Component
4
4
Infusion or Flow Problem
4
4
Material Deformation
4
4
Sharp Edges
4
4
Device Dislodged or Dislocated
4
4
Activation Problem
3
3
Material Twisted/Bent
3
3
No Flow
3
3
Maintenance Does Not Comply To Manufacturers Recommendations
3
3
Blocked Connection
3
3
Device Handling Problem
3
3
Activation Failure
3
3
Unintended Ejection
3
3
Material Fragmentation
3
3
Inadequate or Insufficient Training
3
3
Unsealed Device Packaging
2
2
Defective Component
2
2
Difficult to Insert
2
2
Inability to Irrigate
2
2
Fracture
2
2
Mechanical Problem
2
2
Difficult to Advance
2
2
Device Fell
2
2
Unexpected Shutdown
1
1
Suction Failure
1
1
Device Operates Differently Than Expected
1
1
Device-Device Incompatibility
1
1
Noise, Audible
1
1
Output Problem
1
1
Packaging Problem
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Migration or Expulsion of Device
1
1
Misconnection
1
1
Loose or Intermittent Connection
1
1
Fluid/Blood Leak
1
1
Accessory Incompatible
1
1
Partial Blockage
1
1
Component Falling
1
1
Corroded
1
1
Degraded
1
1
Disconnection
1
1
Entrapment of Device
1
1
Device Displays Incorrect Message
1
1
Output above Specifications
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Device Difficult to Setup or Prepare
1
1
Material Puncture/Hole
1
1
Product Quality Problem
1
1
Difficult to Remove
1
1
Material Rupture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
126
126
No Consequences Or Impact To Patient
24
24
Capsular Bag Tear
24
24
Foreign Body In Patient
22
22
No Known Impact Or Consequence To Patient
17
17
Device Embedded In Tissue or Plaque
9
9
Eye Injury
8
8
Hemorrhage/Bleeding
7
7
Retinal Tear
7
7
Vitreous Hemorrhage
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Retinal Injury
4
4
Insufficient Information
4
4
Vitrectomy
4
4
No Patient Involvement
4
4
Corneal Clouding/Hazing
4
4
Corneal Edema
4
4
Corneal Abrasion
2
2
Endophthalmitis
2
2
Failure of Implant
2
2
Keratitis
2
2
Tissue Damage
2
2
No Code Available
2
2
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Zonular Dehiscence
1
1
Vitritis
1
1
Shock
1
1
Rupture
1
1
Discomfort
1
1
Injury
1
1
Needle Stick/Puncture
1
1
Prolapse
1
1
Loss of Vision
1
1
Visual Disturbances
1
1
Vitreous Loss
1
1
Pain
1
1
Retinal Detachment
1
1
Inflammation
1
1
Corneal Perforation
1
1
Edema
1
1
Hyphema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Anodyne Surgical
II
Jun-11-2021
2
Beaver Visitec
II
Mar-27-2019
3
Dutch Ophthalmic USA, Inc.
II
Jul-19-2021
4
Ellex iScience, Inc.
II
Oct-01-2018
5
Mckesson Medical-Surgical Inc. Corporate Office
II
Aug-26-2022
6
Vitreq Bv
II
Jan-24-2020
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