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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
43
43
2022
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
34
34
Adverse Event Without Identified Device or Use Problem
19
19
Particulates
16
16
Break
12
12
Complete Blockage
11
11
Obstruction of Flow
10
10
Insufficient Information
7
7
Material Opacification
6
6
Material Separation
6
6
Fitting Problem
6
6
Detachment Of Device Component
4
4
Infusion or Flow Problem
4
4
Activation, Positioning or Separation Problem
4
4
Device Dislodged or Dislocated
4
4
Sharp Edges
4
4
Contamination /Decontamination Problem
4
4
Connection Problem
3
3
Activation Failure
3
3
Maintenance Does Not Comply To Manufacturers Recommendations
3
3
Activation Problem
3
3
Unintended Ejection
3
3
Device Handling Problem
3
3
Inadequate or Insufficient Training
3
3
Material Fragmentation
3
3
Device Contamination with Chemical or Other Material
3
3
Fracture
2
2
Unsealed Device Packaging
2
2
Material Twisted/Bent
2
2
Mechanical Problem
2
2
Difficult to Advance
2
2
Difficult to Insert
2
2
Loose or Intermittent Connection
1
1
Output above Specifications
1
1
Material Rupture
1
1
Device Displays Incorrect Message
1
1
Component Falling
1
1
Disconnection
1
1
Entrapment of Device
1
1
Scratched Material
1
1
Degraded
1
1
Blocked Connection
1
1
Device Difficult to Setup or Prepare
1
1
Device Slipped
1
1
Noise, Audible
1
1
No Flow
1
1
Output Problem
1
1
No Apparent Adverse Event
1
1
Unexpected Shutdown
1
1
Difficult to Remove
1
1
Device Operates Differently Than Expected
1
1
Migration or Expulsion of Device
1
1
Device Fell
1
1
Defective Component
1
1
Device-Device Incompatibility
1
1
Corroded
1
1
Misconnection
1
1
Product Quality Problem
1
1
Inadequacy of Device Shape and/or Size
1
1
Accessory Incompatible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
48
48
No Consequences Or Impact To Patient
24
24
Capsular Bag Tear
22
22
Foreign Body In Patient
18
18
No Known Impact Or Consequence To Patient
17
17
Device Embedded In Tissue or Plaque
9
9
Eye Injury
7
7
Retinal Tear
6
6
Hemorrhage/Bleeding
5
5
Vitrectomy
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Retinal Injury
4
4
No Patient Involvement
4
4
Insufficient Information
3
3
Vitreous Hemorrhage
3
3
Corneal Abrasion
2
2
Tissue Damage
2
2
Endophthalmitis
2
2
No Code Available
2
2
Corneal Clouding/Hazing
2
2
Keratitis
2
2
Pain
1
1
Discomfort
1
1
Injury
1
1
Needle Stick/Puncture
1
1
Hyphema
1
1
Zonular Dehiscence
1
1
Rupture
1
1
Corneal Perforation
1
1
Failure of Implant
1
1
Visual Disturbances
1
1
Vitreous Loss
1
1
Vitritis
1
1
Unspecified Tissue Injury
1
1
Edema
1
1
Loss of Vision
1
1
Corneal Edema
1
1
Inflammation
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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